Infant calming/sleep-aid, sids prevention device, and method of use

ABSTRACT

An infant calming/sleep-aid/SIDS detection device is provided that includes a main moving platform that moves in a variable manner with accompanying variable sound generation, the sound and motion adapted to calm a fussy baby, induce sleep, and maintain sleep under normal conditions. The device may also have a sensor for detection of pauses in breathing and/or detection of resultant biological changes related to breathing pauses and respond with appropriate stimuli to arouse the baby and allow breathing to recommence.

CLAIM OF PRIORITY

This application is a divisional of U.S. patent application Ser. No.14/448,679 filed on Jul. 31, 2014 (HAPI-0003-U01).

U.S. patent application Ser. No. 14/448,679 claims the benefit of thefollowing provisional applications: U.S. patent application Ser. No.61/860,752, filed Jul. 31, 2013 (HAPI-0002-P01) and U.S. patentapplication Ser. No. 61/975,541, filed Apr. 4, 2014 (HAPI-0003-P01).

U.S. patent application Ser. No. 14/448,679 is a continuation in part ofU.S. patent application Ser. No. 14/353,258, filed Apr. 21, 2014(HAPI-0001-U01), which is a 371 national stage application ofInternational application PCT/US2012/061069 filed on Oct. 19, 2012,which claims the benefit of U.S. patent application Ser. No. 61/549,627,filed Oct. 20, 2011.

Each of the above applications is incorporated herein by reference inits entirety.

FIELD

This disclosure relates to an infant calming, sleep promoting and SIDSpreventing device.

DESCRIPTION OF THE RELATED ART

Persistent crying and poor infant sleep are perennial and ubiquitouscauses of parent frustration. During the first months of life, babiesfuss/cry an average of about 2 hours/day and wake two to three times anight. One in six infants is brought to a medical professional forevaluation for sleep/cry issues.

Infant crying and parental exhaustion are often demoralizing anddirectly link to marital conflict, anger towards the baby and impairedjob performance. In addition, they are primary triggers for a cascade ofserious/fatal health sequelae, including postpartum depression (whichaffects about 15% of all mothers and about 25 to about 50% of theirpartners), breastfeeding failure, child abuse and neglect, infanticide,suicide, unsafe sleeping practices, SIDS/suffocation, cigarette smoking,excessive doctor visits, overtreatment of infants with medication,automobile accidents, dysfunctional bonding, and perhaps maternal andinfant obesity.

Traditional parenting practices have utilized swaddling, rhythmic motionand certain sounds to soothe fussing infants and promote sleep (byreducing sleep latency and increasing sleep efficiency). “Sleep latency”may be defined as the length of time between going to bed and fallingasleep. “Sleep efficiency” may be defined as the ratio of time spentasleep (total sleep time) to the amount of time spent in bed.

Swaddling, rhythmic motion and certain sounds imitate elements of ababy's in utero sensory milieu and activate a suite of subcorticalreflexes, called the “calming reflex,” during the first 4-6 months of ababy's life. After that time, these stimuli can still promote infantsleep, but they do so by activating a conditioned response.

Swaddling is a method of snug wrapping with the arms restrained at thebaby's sides. This imitates the confinement babies experience in thewomb and the continual touch they experience from the soft lining of theuterine walls. Swaddling also inhibits startling and flailing, whichoften interrupts sleep and starts/exacerbates crying.

Rhythmic, jiggling motion replicates the movement fetuses experiencewhen the mother is walking. The motion stimulates the vestibularapparatus in the semicircular canals of the inner ear. A specific,rumbling noise imitates the sound created by the turbulence of the bloodflowing through the uterine and umbilical arteries. In utero, the soundlevel babies hear has been measured at between 75 and 92 dB. Each babyhas a specific and distinctive unique mix of motion and sound that mostefficiently activates his or her calming reflex. This preferred mixstays consistent through the first months of life (i.e. babies whorespond best to swaddling plus jiggling continue to respond to thosemodalities over time and don't abruptly switch their preference toswaddling plus sound).

The calming reflex has several constant characteristics. It is triggeredby a stereotypical sensory input; produces a stereotypical behavioraloutput; demonstrates a threshold phenomenon (i.e. stimuli that are toomild may not be sufficient to activate a response); has a threshold thatvaries between individuals (i.e. is higher or lower for any givenchild); the threshold varies by state (e.g. fussing and crying raise thelevel of stimulation required to exceed threshold and bring about reflexactivation); the reflex is almost irresistible at first, but wanes after3-4 months of age.

Since the nominal level of a stimulus needed to reach the triggeringthreshold of the calming reflex differs from one child to the next,failure to exceed a particular child's threshold level often results ina total absence of a calming response. For example, slow smooth motionmay calm one upset infant, yet be too subdued to calm another. Likewise,moderately loud sound (e.g., at a level of about 78 dB) sound may reachthe calming threshold for one child, but be insufficient to calmanother. Once triggered, the stereotypical output of the calming reflexis a reduction of motor output and a more tranquil state (quiet alertstate or sleep). In this context, the word “state” describes an infant'slevel of attention to and interaction with the environment. Infantsexperience at least six identifiable states in this context: quietsleep, active sleep, drowsiness, quiet alert, fussing and crying. Theintensity of sound and motion needed to trigger any particular baby'scalming reflex is substantially greater than the levels needed to keepthe calming reflex activated.

However, despite the convenience, efficacy and availability ofswaddling, rhythmic motion and sound, these methods fail to calm andpromote sleep in a large portion of the infant population because theyare not being applied correctly. When parents fail to reduce infantcrying and promote sleep, they often bring the baby into their own bed.However, this is problematic because sharing a bed with a parent hasbeen proven to raise an infant's risk of Sudden Infant Death Syndrome(SIDS) and accidental suffocation (which the US Centers for DiseaseControl reports has been increasing by 14% per year for approximatelytwenty years). The hazard of bed sharing is further elevated if theparent is extremely fatigued. Like inebriation, exhaustion reduces adultjudgment and responsiveness. As many as 50% of new parents reportsleeping fewer than 6 hours/night, the level demonstrated in adults tocause a level of impairment of attention and cognition comparable toinebriation. For this reason, bed sharing with an exhausted parentincreases the SIDS risk and the suffocation risk (from accidentaloverlaying of the parents body over the infant's head, pulling beddingover the baby, etc.).

Other behaviors that stressed, exhausted parents engage in also directlyraise the risk of SIDS and suffocation (e.g. cigarette smoking,cessation of breast feeding, falling asleep with the baby on a couch,placing the baby on the stomach to sleep). Medical authorities recommendparents avoid bed sharing. However, cribs too can be problematic. Babiessleeping supine in cribs have a higher risk of plagiocephaly (flatteningof the skull), which may require expensive and inconvenient medicaltreatment, and may result in permanent deformity. A crib's flat, quiet,nonmoving surface is devoid of the swaddling, rhythmic motion and soundthat can activate the calming reflex or conditioned response and reducecrying and sleep latency and increase sleep efficiency.

In an attempt to improve infant sleep in cribs, parents have employedseveral methods (prone sleeping, swaddling, rocking motion, sound),however each is problematic. For example, the prone position isassociated with a 3-4 fold increased risk of SIDS. Unswaddled babies canroll to the stomach position (prone), which is associated with an 8-19fold increased risk of SIDS. Swaddled babies can roll prone, which isassociated with a 12-fold increased risk of SIDS. Rocking motiondelivery systems (e.g. swings, cradles and hammocks) may all presentproblems. The motion of infant swings is often insufficient to calm afussy baby and induce sleep. When sitting in a swing, a baby's head canroll forward and create an airway obstruction, leading to death. Cradlesand hammocks require parents to be the motion-powering energy source,and thus can be done for only a limited part of the sleep period. Also,they can accidentally cause a supine baby to roll to he side or stomachor become wedged into the side wall of the sleeper. Sound deliverydevices (e.g. fans, air filters, hair driers, sound machines and whitenoise CDs) may be cumbersome and expensive and the volume, quality orfrequency profile of the sound they produce may be excessive or toodifferent from in utero sound to be effective.

Over the past twenty years, attempts have been made to engineertechnological methods to create infant calming/sleep devices to deliversound and motion more conveniently. These current infant calming/sleepdevices typically deliver fixed and unchangeable motion and sound. Thisis a problem because each baby has a different mix of sound and motionthat most efficiently calms the child's crying. For example, some babiesrespond best to swaddling plus motion, while others are not calmedunless they have swaddling, motion plus white noise sound. Anotherproblem with fixed motion and sound infant calming/sleep devices is thateach baby has a unique level of motion and sound that induces calmingand sleep most efficiently. For example, slow rocking may reduce sleeplatency for one infant, yet be too subdued to do so in another infant.And, quiet sound may be sufficient to increase sleep efficiency for onebaby, but not another. Devices that deliver constant sound may alsoexpose a baby to unhealthy levels of sound, if they are set at too higha volume.

Still another problem with fixed motion and sound infant calming/sleepdevices is that the intensity of the stimuli needed to activate thecalming reflex and induce calm and sleep varies substantially as achild's state changes. For example, most fussy babies require morevigorous, jiggling motion (with rapid acceleration-deceleration) andmore vigorous sound inputs (as loud as a vacuum cleaner or hair drier—75to 95 dB). On the other hand, calm, sleepy babies need less vigorousinputs. Further, current infant calming/sleep devices do not continueall night long; do not deliver optimal sound and motion for triggeringthe calming reflex; do not increase and decrease their sensory input ina step-wise fashion to vary the sensory input intensity to give the babythe most effective level of stimulation with the minimum exposure tohigh levels of sound; lack the ability to gradually increased thesensory input over the first weeks of life and to gradually wean a babyoff the stimuli as he or she ages.

In addition, crib death or SIDS (Sudden Infant Death Syndrome) is aleading cause of infant mortality. Approximately 2500 US babies die eachyear from SIDS during the first year of life. The peak occurrence isfrom 2-4 months of age, with 80% of the victims being under 4 months and90% being under 6 months of age.

In the 1990's a program to reduce SIDS deaths called “Back to Sleep” wasintroduced. At that time, it was discovered that sleeping on the stomachwas a key triggering factor in SIDS, so caregivers were instructed toplace babies on their backs for sleeping. Within less than a decade, therate of SIDS dropped in half, however, since that time, the SIDSincidence has been not diminished. Furthermore, while the exact cause ofSIDS is unknown, the primary cause is believed to be immaturity of thebreathing regulatory system in the brain. In essence, it seems thatbabies “forget” to breath and their internal alarm system does notreliably arouse them to recommence breathing. Once breathing stops, thebody becomes more and more hypoxemic and acidotic, leading to a downwardspiral of reduced heart rate, dropping blood pressure, cardiovascularcollapse and death. Studies have indicated that the risk of stomachsleeping may indeed predispose babies to SIDS by reducing infantarousability.

In the hospital setting, the use of an infant monitor immediately alertsthe healthcare workers if an infant stops breathing. The health careworkers can often resuscitate the infant with simple stimulation (e.g.vigorous jiggling), without the need of oxygen or formal CPR.

In the home setting, however, studies have not shown that using acardiorespiratory monitor reduces the incidence of SIDS. This lack ofeffect may be because, 1) the parent responding to the alarm may notknow how to resuscitate the baby; 2) the parent may be panicked andincapable of resuscitating the baby; 3) the baby may be so hypoxic andacidotic, that, by time the parent arrives at the scene, an irreversiblecardiorespiratory collapse has already been precipitated.

However, a device that can begin vigorous stimulation of the baby withinseconds of the baby stopping breathing (apnea) may be able to arouse theminimally depressed baby and reinitiate the breathing sequence before adownward cardiovascular spiral has occurred. The “Back to Sleep” programhas proven that simple interventions can lead to a profound reduction inmortality by virtue of helping babies be slightly more aroused, as theyare in the supine position. In other words, it may not take a greatamount of sensory input maintain the baby in a mode of regular breathingor to return the baby to normal breathing after a brief, transientcessation. Also, two studies have shown that supine swaddling isassociated with a reduction in SIDS. Swaddling has been shown toincrease arousability, especially during active sleep.

Therefore, a need exists for an infant calming/sleep system thatovercomes or minimizes the above-mentioned problems.

SUMMARY

This disclosure is generally directed to devices and methods for aidingcalming and safe sleep of an infant. In embodiments, an infantcalming/sleep-aid device is provided that includes a main movingplatform that moves in a variable manner with accompanying variablesound generation, each adapted to calm a baby, induce sleep, andmaintain sleep. This device can be independently controlled, from thedevice itself, or via communication with a mobile device applicationthat also delivers users various forms of information about sleep, theirbaby, etc. Also, a secure sleep sack design may be provided whichprevents accidental rolling to the potentially risky prone position.Furthermore, this device may contain a sensor to monitor one or more ofthe baby's biometrics to detect when the baby has temporarily stoppedbreathing. In that case, the device will sound an alarm to summons thecaregiver and commence vigorous motion and sound—similar to theintervention used by medical personnel to arouse apneic infants in thehospital—before the baby becomes acidotic and bradycardic. The devicecan also be programmed by the parent to call 911 or local emergencyservices in case of cessation of breathing of the infant.

In one embodiment, an infant calming/sleep-aid device is provided thatincludes a main moving platform that moves in a reciprocating manner. Anactuator drives the reciprocating movement of the main moving platform.An optional moving head platform may be linked to the main movingplatform to reciprocate in response to reciprocating movement of themain moving platform. In some embodiments, at least one of a motionsensing device and a sound sensing device are, respectively, at orproximate to main moving platform or the moving head platform. A logicsystem links at least one of the motion sensing device and the soundsensing device to the main moving platform, whereby signals detected byat least one of the motion sensing device and the sound sensing devicecause the logic circuit to modulate the movement of the main movingplatform and the intensity of the sound produced by the sound generationsystem.

In some embodiments, the infant calming/sleep-aid device includes arigid base and a main movement linkage or bearing extending from thebase. A moving infant support is mounted on the main movement linkage orbearing, whereby the platform is movable on the main movement linkage orbearing relative to the base. An actuation assembly that controlsmovement of the moving platform about the main movement linkage orbearing relative to the rigid base includes an actuator mounted to therigid base.

In some embodiments, a method for aiding the calming of a fussy infantor the sleep of an infant, includes the step of moving the infant on theplatform in a reciprocating or rotating manner about an axis thatintersects the infant at a 90° angle to a major plane of the surfacesupporting the infant, repetitively moving the supporting surface up anddown, a combination of such movements, or others. For example, motion ofthe platform in other planes in addition to a horizontal plane, such asa swinging motion, or rotating motion around a horizontal axis, is alsopossible.

The movements may be made in an adaptive manner. In some embodiments, atleast one of a sound generated by a sound generating device and areciprocating or repetitive or rotating movement may be modulated in anupdating and adaptive matter by a logic circuit-controlled actuation inresponse to at least one of the sound of the infant and the motion ofthe platform. In embodiments, sound may delivered to an infant in thedevice but not motion if the infant is not securely attached to theplatform. In embodiments, motion may delivered to an infant in thedevice but not sound, at the parents choice.

The device and method have many advantages. For example, the device andmethod provide for modulation of the movement of an infant in anupdating and adaptive manner. The rapidly accelerating and deceleratingmotion of the device, which induces the infant's head to accelerate anddecelerate over a short distance in a safe and specifically controlledmanner, imitates the sensations that babies experience before birth inthe womb. During the first 6 months of an infant's life these sensationsinduce the infant's natural calming reflex. In addition, after just daysto weeks of time, these cues begin to trigger a conditioned response.The device's specifically designed motion and sound, along with itsadaptive control system reduce irritability during awake time andimprove infant sleep (specifically reducing irritability during periodsof sleep, reducing sleep latency and increasing sleep efficiency) forbabies up to at least twelve months of age.

As further steps to reduce SIDS, the infant calming/sleep systemdescribed herein may provide babies with a secure swaddle or sleep sack,as two studies have shown that a supine swaddle may reduce SIDS. Thesecure sleep sack described herein is intended to: 1) preventoverheating; 2) promote greater air flow; 3) prevent accidental rollingto the stomach when the baby is unsupervised. A sensor to detect whenthe baby stops breathing to cue/trigger a vigorous response and thesending of an alarm to parent may also be included in the infantcalming/sleep system. This sensor can cue or trigger a rapid response ofvigorous motion/sound and generate an alarm to summons the caregiver orsend an automatic message to call for emergency medical services, suchas via a WIFI connection.

In embodiments, a method for preventing SIDS includes the steps ofproviding a sleep device comprising a platform for supporting an infant;monitoring the infant with a sensor that generates a signal indicativeof at least one of a motor status or a physiologic status of the infant;receiving and analyzing, by a control system of the sleep device, thegenerated signal indicative of the motor status or the physiologicstatus of the infant; generating, by the control system of the sleepdevice, at least one output that controls at least one of a motion ofthe platform and a sound directed to the infant if a distressed statusof the infant is detected based on the analyzed signal; and generatingat least one of reciprocating motion of the platform and a sounddirected to the infant in response to the at least one output.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 is a perspective view of an exemplary embodiment of an infantcalming/sleep-aid device, with a depiction of an infant asleep insidethe device.

FIG. 2 is a perspective view of the infant calming/sleep-aid device ofFIG. 1 with swaddle fastening straps and without an enclosure.

FIG. 2a is a perspective view of the infant calming/sleep-aid device ofFIG. 1 with swaddle fastening clips integral to the swaddle and withoutan enclosure.

FIG. 3 is a perspective view of the infant calming/sleep-aid device ofFIG. 2, showing apparatus beneath the main moving platform in brokenlines.

FIG. 4 is a plan view illustrating components supporting the main movingplatform of the infant calming/sleep-aid device of FIG. 3, with therigid base and main moving platform shown in outline.

FIG. 5 is a side view of the infant calming/sleep-aid device shown inFIG. 4, taken along line 5-5.

FIG. 6 is a side view of the infant calming/sleep-aid device shown inFIG. 4.

FIG. 6a illustrates a drive motor of the infant calming/sleep-aid deviceshown in FIG. 4 or of other embodiments of the infant calming/sleep-aiddevice.

FIG. 6b illustrates an exemplary location of a drive motor on anotherexemplary embodiment of an infant calming/sleep-aid device.

FIG. 6c illustrates a cross sectional view of an embodiment of theinfant calming device/sleep-aid device showing the drive motor.

FIG. 7 is a perspective view of yet another exemplary embodiment of thecalming/sleep-aid device of the invention, showing components of thedevice beneath the main moving platform in broken lines.

FIG. 8 is a plan view of components supporting the main moving platformof the calming/sleep-aid device of FIG. 7, with the rigid base and mainmoving platform shown in outline.

FIG. 9 is a side view of the embodiment of the device shown in FIG. 7.

FIG. 10 is a schematic representation of one embodiment of a softwarecontrol system of the calming/sleep-aid device, along with inputs andoutputs of the software control system.

FIG. 11 is a schematic representation of one embodiment of a cryingdetection module of the calming/sleep-aid device.

FIG. 12 is a schematic representation of one embodiment of a motionanalysis module of the calming/sleep-aid device.

FIG. 13 is a schematic representation of one embodiment of a behaviorstate machine module.

FIG. 13a is a schematic representation of one embodiment of a biometricsensor module.

FIG. 14 is a schematic representation of one embodiment of an audiogeneration module.

FIG. 15 is a schematic representation of a motion generation module.

FIG. 16 is a schematic representation of a motion generation module.

FIGS. 17-21 illustrate another exemplary embodiment of an infant calmingdevice having a moving main platform with an integral head platformportion.

FIG. 22 is schematic diagram of control system related components of anexemplary infant calming/sleep-aid device.

FIG. 23a illustrates another exemplary embodiment in a perspectivepartially cut-away view of an infant calming/sleep-aid device viewedfrom one end of the device, and which can incorporate the control systemof FIG. 22.

FIG. 23b is an exploded perspective view of the infant calming/sleep-aiddevice of FIG. 23a , showing individual components of the infantcalming/sleep-aid device.

FIGS. 23c and 23d are perspective views of the infant calming/sleep-aiddevice of FIG. 23 b.

FIGS. 23e-23h illustrate exemplary embodiment of leg connectors of theinfant calming/sleep aid device of FIG. 23b , which are used to attachlegs.

FIG. 24a is a view of the attachment mechanism to attach a secure sleepsack to the infant calming/sleep aid device of FIG. 23 b.

FIG. 24b is a top perspective view of the infant calming/sleep-aidshowing the part of the attachment mechanism that allows a secure sleepsack to be attached to the infant calming/sleep-aid device of FIG. 23 b.

FIGS. 25a-25j are views of exemplary secure sleep sacks.

FIG. 26a illustrates views of layers displayed by a user interface foruse with the infant calming/sleep-aid device of FIG. 22.

FIG. 26b illustrates views of sliders displayed by a user interface foruse with the infant calming/sleep-aid device of FIG. 22.

FIG. 26c illustrates views of blossoms displayed by a user interface foruse with the infant calming/sleep-aid device of FIG. 22.

FIG. 26d illustrates additional views displayed by a mobile applicationuser interface for use with the infant calming/sleep-aid device of FIG.22.

FIG. 27 illustrates additional views displayed by an exemplary mobiledevice application user interface for use with the infant calmingdevice.

FIGS. 28 and 29 illustrates exemplary embodiments of a clip or switchfor control purposes of the device.

DETAILED DESCRIPTION

In an exemplary embodiment, shown in FIGS. 1 through 6, infantcalming/sleep-aid device 10 includes an enclosure 12 about an infant 14.Enclosure 12 surrounds main moving platform 16. Main moving platform 16may be made from wood-based particleboard with an injection moldedsupport tray or the entire platform may be injection molded. Theinjection molded support tray may provide stiffening ribs, attachingfeatures, and the like. As can be seen in FIG. 2, main moving platform16 includes base 18, moving head platform 19, padding 20 and clothcovering 22. Secure sleep sack fastening straps 24 extend from mainmoving platform 16 for securing infant 14 in suitable secure sleep sack26. As can be seen in FIG. 2a , sleep sack fastening straps may takeother forms such as attachment clips and may be integral to the sleepsack 26. This embodiment includes a head pad insert 28 that supports thehead of infant 14. Preferably, head pad insert 28 includes a gel inorder to reduce the risk of plagiocephaly. Handles 30 extend laterallyfrom main moving platform 16. Main moving platform 16 is supported androtatable about a main support shaft (not shown) that is fixed to rigidbase 32. Rigid base 32 may be made from molded plastic, stamped metal,and the like. Control panel 34, which includes speed control knobs 35,status lights 37 and controls 39 for microphone 38. Rigid base controlelectronics 36 may include drive electronics of the infantcalming/sleep-aid device 10, as well as other sensors, such as anaccelerometer or biometric sensor (not shown).

In another representative view of infant calming/sleep-aid device 10 ofFIG. 2, shown in FIG. 3, main moving platform 16 is supported by mainsupport shaft 40 at main rotation bearing 42. Moving head platform 19supports head pad insert 28 and is rotatable about head rotation bearing46 through arm 48 extending between head rotation bearing 46 and movinghead platform 19. Motion sensing device 50, such as an accelerometer, atmoving head platform 44 detects motion of moving head platform 19.Microphones 38 at moving head platform 19 detect sound emitted by theinfant (not shown) when supported by infant aid sleep device 10.Speakers 52, supported by brackets 54 mounted on rigid base 18, arelocated directly beneath moving head platform 19. Springs 56 linkingeither side of moving head platform 19 to main moving platform 16 dampenmotion of moving head platform 19 relative to main moving platform 16during reciprocal motion of moving head platform 19 induced byreciprocating motion of main moving platform 16.

Reciprocating motion of main moving platform 16 about main support shaft40 is about an axis that is orthogonal to a major plane of main movingplatform 16. Reciprocating motion of main moving platform 16 is drivenby actuator assembly 58.

In some embodiments, the body and the head of the infant can be out ofphase. For example, at relatively slow speeds, the motion of the head ofthe infant can be in the same direction as that of the motion of theupper body of the infant. At relatively high speeds, the reciprocalmotion of the head of the infant can be in the opposite direction asthat of the upper body of the infant. In another embodiment of theinvention (not shown), reciprocal motion of the head of the infant canbe in some other direction, such as orthogonally relative to the planeof the main support platform.

Actuator assembly 58 includes drive motor 60 mounted to rigid base 32and gear assembly 62 linked to drive motor 60 and also mounted to rigidbase 32. Drive motor 60 may be an electric motor with a reciprocatingdrive disk and push/pull rod.

Actuation of drive motor 60 causes rotation gear assembly 62 to driveeccentric drive plate 64 about an axis normal to a major plane of rigidbase 32. Eccentric drive plate 64 is linked to swing arm plate 66 ofactuator assembly 58 that extends from eccentric drive plate 64 to rodend 68 of screw 70 and is pivotally mounted to rod end 68 of screw 70.Screw 70 is mounted to amplitude modulation assembly 72. Amplitudemodulation assembly 72 includes amplitude modulation motor 74, nut 76,mounted on nut frame 78, which swivels on rotation bearing 80 mounted torigid base 32. The axis of rotation of nut frame 78 on rotation bearing80 is, like that of eccentric drive plate 64, normal to a major plane ofrigid base 32. Actuation of amplitude modulation assembly 72 causesmovement of screw 70 along its major longitudinal axis to thereby causerod end 68 to become more proximate or less proximate to amplitudemodulation assembly 72. Arm 82 extends from an end of screw 70 oppositeto rod end 68 to elastic actuator catch bracket 84, which is mounted onbase 18 of main moving platform 16. Arm 82 extends through an openingdefined by elastic actuator catch bracket 84 and is linked to mainmoving platform 16 by springs 86, 88 held in place on either side ofelastic actuator catch bracket 84 by nuts 90, 92, respectively.

Actuation of actuation assembly drive motor 60 causes rotation ofeccentric drive plate 64 about an axis normal to a major plane of rigidbase 32 which, in turn, causes reciprocal motion of swing arm plate 66roughly along a major longitudinal axis of swing arm plate 66. Suchreciprocal motion of swing arm plate 66 causes rod end 68 to move in areciprocal motion from side-to-side of a major longitudinal axis ofscrew 70 which causes reciprocal rotation of nut frame 78 about an axisnormal to major plane rigid base 18 and side-to-side motion of theopposite end of screw 70 opposite that of rod end 68 of screw 70. Suchside-to-side movements of the opposite end of screw 70 causes reciprocallongitudinal movement of arm 82 extending through the opening defined byelastic actuator catch bracket 84.

Resistance to such reciprocal motion of arm 82 causes alternatingreciprocal compression and relaxation of springs 86, 88, which therebycauses reciprocal motion of main moving platform 16 about main supportshaft 40 linking main moving platform 16 to rigid base 32.

The amplitude of reciprocal motion of main moving platform 16 about mainsupport shaft 40 is controlled by the location of screw 70 relative toamplitude modulation assembly 72. For example, if actuation of amplitudemodulation assembly 72 causes rod end 68 to become more proximate toamplitude modulation assembly 72, the side-to-side motion of theopposite end of screw 70 will become greater, thereby causing theamplification of reciprocal motion of main moving platform 16 about mainsupport shaft 40 to increase. Conversely, actuation of amplitudemodulation assembly 72 to cause rod end 68 of screw 70 to become moreremote from amplitude modulation assembly 72 will diminish theside-to-side motion of opposite end of screw 70, thereby reducing theamplitude of reciprocal motion of main moving platform 16 about mainsupport shaft 40.

Reciprocal motion of main moving platform 16 may cause a delayedreciprocal motion of moving head platform 44 about head rotation bearing46. The reciprocal motion of moving head platform 44, although delayed,may have greater amplitude about main support shaft 40 because of therotation of moving head platform 44 about head rotation bearing 46.However, the amplitude of reciprocal motion of moving head platform 44about head rotation bearing 46 may be dampened by springs 56.

Nevertheless, the reciprocal motion of main moving platform 16 andmoving head platform 44 about main support shaft 40 is measured bymotion sensing device 50 at moving head platform 44. Measurements bymotion sensing device 50 are relayed back to control panel 34 and rigidbase control electronics 36 which, alone, or optionally, in combinationwith external computer software programming, modulate actuator assemblydrive motor 60 and amplitude modulation motor 74. Motion detection bymotion sensing device 50 can also, optionally, modulate computerprogramming to affect selection and volume of sounds emitted by speakers52. Microphones 38, in addition, or optionally, receive acousticalsignals that can be fed back through rigid base control electronics 36or/and control panel 34 to software, either on-board or remote frominfant calming/sleep-aid device 10, that further modulates actuatorassembly drive motor 60, amplitude modulation motor 74 and/or soundsemitted from speakers 52. Various control algorithms associated withmodulation of actuator assembly drive motor 60, amplitude modulationmotor 74 and speakers 52 will be more fully discussed below.

In one embodiment, the device allows for a reciprocating motion at0.5-1.5 cycles per second (cps) of ˜2″ excursions, but if the baby isfussy the device responds by delivering a smaller excursion (e.g. <1.3″)at a faster rate (˜2-4.5 cps). This fast and small motion delivers thespecific degree of rapid acceleration-deceleration force to thesemicircular canals in the vestibular mechanism of the inner ear that isrequired to activate the calming reflex.

Also, the reciprocating motion typically has a maximum amplitude of lessthan 1.3 inches during the rapid phase of motion (−2-4.5 cps), furtherensuring safety of the infant.

In one embodiment, the biometric sensor monitors the infant andgenerates a signal indicative of a respiration status or acardiovascular status of the infant, such as to detect when the baby haspaused breathing for a predetermined period or time, or has acardiovascular collapse, such as indicated by a heart rate below apredetermined threshold, or the like. The sensor signal can be fed backthrough rigid base control electronics 36 or/and control panel 34 to acontrol system such as software, either on-board or remote from infantcalming/sleep-aid device 10. The control system may receive and analyzethe signal to determine whether a distressed status of the infantexists, and further may act, such as to generate an output to controlmodulation of the actuator assembly drive motor 60, amplitude modulationmotor 74, or generate a telephone call to emergency services via Wi-Ficonnection, and/or generate alerting and stimulating sounds that may beemitted from speakers 52. An alarm can be directed to the infant'scaretakers as well.

In some embodiments, in response to detection of infant distress, bothvigorous motion of the platform and a loud sound can be provided. Forexample, providing motion of the platform at a frequency greater than0.5 Hz and an amplitude that is greater than 1 inch, along with soundhaving an intensity of at least 65 dB, may provide appropriatestimulation of the infant. Of course, other amounts of stimulation arealso envisioned.

FIG. 6A illustrates an exemplary and non-limiting embodiment of a drivemotor 60. Drive motor 60 may include motor case 600, motor 602, motorgear 603, motor case bottom 604, release button 606, button springs 616,screw 608, contact pin 610, metal plate 612, and the like. Motor case600 may be made from an acrylonitrile butadiene styrene (ABS) plasticand the like. Motor 602 may be a 12V 300 RPM motor and the like. Motorgear may be made from polyoxymethylene (POM) plastic and the like. Motorcase bottom 604 may be made from ABS plastic and the like. Releasebutton 606 may be made from ABS plastic and the like. Button spring 616may be made from stainless steel and the like. Screw 608 may be M3 HEXflat head 15 mm long screw, made from stainless steel, and the like.Contact pin 610 may be made from stainless steel and the like. Metalplate 612 may be made from stainless steel and the like.

FIG. 6B illustrates the drive motor location 614 of the drive motor 60in an embodiment of the infant calming/sleep-aid device 2258. FIG. 6Cillustrates a cross sectional view of an embodiment of the infantcalming device/sleep-aid device showing the drive motor.

In another embodiment, shown in FIGS. 7 through 9 calming/sleep-aiddevice 100 includes actuator assembly 102, which substitutes foractuator assembly 58 of the embodiment shown in FIGS. 2 through 6.Specifically, as shown in FIGS. 7 through 9, drive motor 104 ofcalming/sleep-aid device 100 is linked to bearing 106, which is, inturn, leads to the eccentric drive plate 108. Eccentric drive plate 108is connected to push/pull rod 110 that extends through an openingdefined by elastic actuator catch bracket 112. Springs 114 aboutpush/pull rod 110 link push/pull rod 110 to main moving platform 16through elastic actuator catch bracket 112. Springs 114 are serieselastic actuator push-springs; they transfer force from actuatorassembly 102 to catch bracket 112. Balancing dampers 115 beneathpush/pull rod 110 dampen the motion of moving platform 16. Springs 117are pull-balancing springs; they pull on bracket 112 in parallel withbalancing dampers 115 to create the desired smooth sinusoidal motion ofmoving platform 16 at low frequencies and the more square wave, rapidaccelerating/decelerating motion at high frequencies. Injection-moldedplastic features that are parts of the main moving platform 16 may beused to create the desired smooth sinusoidal motion of main movingplatform 16 at low frequencies and the rapid accelerating/deceleratingmotion at high frequencies.

Actuation of drive motor 104 causes reciprocal longitudinal movement ofpush/pull rod 110 through the opening defined by elastic actuator catchbracket 112 and translates that reciprocal movement into reciprocalmotion of main moving platform 16 about main rotation bearing 42, asdoes reciprocal motion of arm 82 through elastic actuator catch bracket84 of the embodiment shown in FIGS. 2 through 6. Other components of theembodiments shown in FIGS. 7 through 9 operate in the same manner asthose of infant calming/sleep-aid device 10 represented in FIGS. 2through 6.

As shown FIG. 10, software control system 120 receives various inputsfrom a variety of sensors or control input devices representing desiredsettings or the like and, based on one or more of these inputs, acts tocontrol one or more of various devices, such as to control sound,motion, and/or lights of the sleep aid device, or to initiate anemergency call or alarm. As shown, the control system 120 processesinputs from microphones 125, from speed control knob 121 (also shown aselement 35 in FIG. 2), and from a three-axis USB accelerometer 123(represented as motion sensing device 50 in FIG. 3), and from abiometric sensor 1002, such as a wireless sensor for detecting one ormore of cardiac and respiratory status. Control system 120 generates oneor more output signals, such as to control speakers 131 (speakers 52 asshown in FIG. 3), and to multichannel USB motor controller 122, whichcontrols actuator assembly drive motor (such as drive motor 60 shown inFIG. 3) and amplitude modulation motor (motor 73 of FIG. 3 or drivemotor 104 of FIG. 7-9). Status lights, such as tricolor USB DEs 121 (orlights 37 such as shown in FIG. 3) can also be controlled. Logic orcontrol modules of software control system 120 can be located on-boardor remotely from the embodiments of infant calming/sleep-aid devices 10,100 shown in FIGS. 2 through 9. The modules may include a cryingdetection module 124 that receives data from microphones 125, and relaysto a behavior state machine module 126 whether or not an infant oninfant calming/sleep-aid device is crying or not crying. Microphones 125may be mounted on the infant calming/sleep-aid device, integrated intothe infant calming/sleep-aid device, included in a sensor that is placedon or attached to the infant, and the like. Biometric sensor module 1002may relay one or more of an infant's physiologic parameters (e.g.,breathing status, temperature, motion status, etc.) to the behaviorstate module 126, or depending on the signal provided by the sensor,directly to a Wi-Fi control Module 1004. Depending upon the inputreceived by behavior state machine module 126, output signals willcontrol motion generation module 128 or audio generation module 130 or aWi-Fi phone connection module 1004. Alternatively, or in addition,output signals from behavior state machine module 126 will modulategeneration of audio data output from audio generation module 130 tospeakers 131, represented as speakers 52 in FIGS. 2 through 9.

Motion generation module 128 receives input from speed control knob 121and information regarding motion of the device 10, 100 from motionanalysis module 132. Actuation of motion generation module 128 willmodulate the actuator assemblies of the embodiments shown in FIGS. 2through 9.

Data received from accelerometer 123 is processed by motion analysismodule 132 to thereby modulate the actuator assembly through motiongeneration module 128 and/or audio generation module 130 to therebycontrol the actuators assemblies or speakers, respectively. In addition,motion analysis module 132 controls status light module 134 to alert,through the status lights, whether motions of the main moving platformand the head platform are nominal or not nominal, or alternatively,through feedback, soothing or not soothing to the infant. “Nominal”, asthat term is defined herein, refers to any and all motion for which thefiltered acceleration signal does not exceed a specified, orpredetermined maximum motion threshold for a specific length of time.The process by which the motion analysis module classifies motion asnominal or not nominal is detailed in FIG. 12 and in the accompanyingtext below.

In one embodiment, the rate of the reciprocating rotation is controlledto be within a range of between about one and about four and one-halfcycles per second (cps) and with an amplitude of the reciprocatingmotion at a center of a head of the infant of between about 0.2 inchesand about 1.3 inches. In anther embodiment, the rate of reciprocatingmotion is within a range of between about 0.5 and about 1.5 cycles persecond and an amplitude of the reciprocating rotation at a center of thehead of the infant is in a range of between about 0.25 inches and about2.0 inches. In differing embodiments, this motion may be parallel to, ororthogonal to the platform supporting the infant's body and head.

In embodiments, the control system 120 may operate in a manner whereinthe intensity of maximum stimulation is increased over the course of thefirst weeks and subsequently weans the infant off the device's motion byincorporating the infant age as a variable used in the behavior statemodule 126. For example, modulation of motion and/or sound may befurther controlled by at least one of the weight of the infant, the ageof the infant, and the duration of the detected sounds made by theinfant.

Referring to FIG. 11, crying detection module 124 receives audio datafrom the microphones of infant calming/sleep-aid devices 10, 100, whichis processed through a digital band-pass filter 136 to generate filteredaudio data. Energy-based threshold 138 receives filtered audio data todetermine whether the audio energy is over threshold or under threshold.Time-based filter 140 receives data from energy-based threshold 138 toprovide an indication as to whether the infant is crying or not crying.The information, as discussed above with respect to software controlsystem 120 (FIG. 10), is received from crying detection module 124 bybehavior state machine module 126 that will then provide signals tocontrol motion generation module 128 or audio generation module 130 orboth.

Motion analysis module 132, shown and represented in more detail in FIG.12, receives a signal from the motion-sensing device of infantcalming/sleep-aid devices 10, 100, at digital filter bank 142. Digitalfilter bank 142 filters the signal to generate a filtered motionamplitude estimate that is used as input to motion generation module 128(FIG. 10). In addition, the filtered motion amplitude estimate passesthrough a range check 144 to determine whether the motion is within asoothing or known soothing range, which is provided to time-based filter146 and provides an indication as to whether a motion is soothing or notsoothing to motion generation module 128 (FIG. 10).

Filtered motion sensor, or accelerometer, data from digital filter bank142 also passes through threshold crossing-based motion frequencyestimator 148 to provide an estimate of motion frequency, which isprovides to motion generation module 128.

Outputted data from threshold-crossing-based motion frequency estimator148 also passes through range check 144 for indicating whether themotion is or is not soothing,

Filtered accelerometer data from digital filter bank 142 also isprocessed to determine whether or not the acceleration exceeds aspecific maximum motion threshold 150 and, depending on the result,processes that data through time-based filter 152 to provide anindication as to whether the motion is nominal or not nominal. Thisindication as to whether the motion is nominal or not nominal is used asinput to motion generation module 128 (FIG. 10), and is additionallyused to control status lights 37 (FIG. 2) via status light module 134(FIG. 10).

As can be seen in FIG. 13, behavior state machine module 126 receivesinformation from crying detection module 124 (FIG. 11) as to whether theinfant is in a state of crying or not crying. This information is usedby the state machine's state transition rules 156 to select an activestate from a library of states 154, thereby outputting a desired motionstate, a desired audio track and/or desired volume/equalizer settings toaudio generation module 130 of FIG. 10.

As can be seen in FIG. 13a , behavior state machine module 126 receivesinformation from biometric sensor module 1002 (FIG. 10) as to whether abiometric measure is normal or not normal. One possible biometricmeasure may be normal if an infant is breathing, not normal if an infantis not breathing, and the like. This information is used by the statemachine's state transition rules 156 to select an active state from alibrary of states 154, thereby outputting a desired motion state, adesired audio track and/or desired volume/equalizer settings, a desiredphone call state, and the like to audio generation module 130 (FIG. 10).Desired alarm state may be a parent alarm state and the like. Desiredaudio track may be a special vigorous white noise track and the like.Desired phone call state may be initiate Wi-Fi phone call to emergencyservices and the like.

Audio generation module 130, represented in FIG. 14, receives signals ofa desired audio track and desired volume/equalizer settings frombehavior state machine module 126 (FIG. 10) and signals of motionanalysis, specifically, whether the motion is nominal or not nominal,from motion analysis module 132 (FIG. 10). Desired audio track may be asound audio track, music audio track, special vigorous white sound audiotrack, and the like. Audio generation module 130 includes a specialvigorous white noise audio track 161, a library of “soothing” audiotracks 160, a digital equalizer/volume control 162 and alarm sound 164.Upon receipt of a new command from motion analysis module 132 (FIG. 10),audio generation module 130 will cross-fade to a desired audio track andvolume, and crossfade to desired equalizer settings. If the motion isnot nominal, then an alarm signal may be output to override the audiosignal with an alarm. The audio signal from the audio generation module130 (FIG. 10) is output to the USB speakers 131 (FIG. 10) of infantcalming/sleep-aid device 10, 100.

At baseline, the audio generator will produce an output of a low-pitch,rumbling sound at about 65 dB to 74 dB. Upon receipt of a new commandfrom crying detection module 124 (FIG. 11), audio generation module 130will cross-fade to a more high pitched audio track and louder volume, atabout 75 dB to 95 dB.

Upon receipt of a new command from behavior state module 126 (FIG. 10),audio generation module 130 will cross-fade to a desired audio track andvolume, and crossfade to desired equalizer settings. If the signalreceived from the behavior state module 126 is indicative of an abnormalbiometric signal that has been detected by the biometric sensor 1002(FIG. 10), for example that an infant is not breathing, then an alarmsignal and special vigorous white sound audio track will be output tooverride the audio signal with an alarm and special vigorous white soundaudio track. The special vigorous white sound audio track signal fromthe audio generation module 130 (FIG. 10) is output to the USB speakers131 (FIG. 10) of infant calming/sleep-aid device 10, 100.

Audio generation module 130 (FIG. 14) receives signals from thebiometric sensor module 1002 (FIG. 10). An abnormal reading, such as areading indicating that an infant is not breathing, will activate adesired audio track, such as a special vigorous white sound audio track,parent alarm and desired volume/equalizer settings. Upon receipt of anew command from biometric sensor module 1002 (FIG. 10), audiogeneration module 130 will cross-fade to a desired audio track andvolume, and crossfade to desired equalizer settings.

Audio generation module 130 (FIG. 14) may receive mild signals thatindicate an infant is awakening. Mild signals may detect that an infantis mildly awakened. Mild signals may be mild motion signals, mild soundsignals, and the like. Mild signals may be sent from a sensor attachedto or worn by an infant. Mild signals may be detected from an infantbefore the infant begins to cry. Audio generation module 130 (FIG. 14)may begin to increase sound levels when mild signals are received.

Two variations of motion generation module are represented in FIGS. 15and 16. In the first embodiment of motion generation module 128, shownin FIG. 10, motion generation module 128 receives a desired motion stateinput from behavior state machine module 126 (FIG. 10), a motionfrequency/amplitude signal from motion analysis module 132 (FIG. 10), adesired system speed signal from speed control knob 121 (FIG. 10), and asignal as to whether a motion is nominal or is not nominal. The “desiredsystem speed” is the setting of speed control knob 121, whereby theoperator can select or limit the motions allowed by infantcalming/sleep-aid device 10, 100. The desired motion state signal goesto lookup within motion generation module 128, which outputs a referencemotor command based on a desired motion state. If the currently activemotor commands are close to the reference motor commands, then the motorcommands are actively adjusted within an allowable envelope via agradient ascent based on observed motion frequency and amplitude. If thecurrent motor commands are not close to the reference motor commands,then the motion generation module will set desired motor commands viapath planning in a motor command space. “Path planning” transitionsmotor settings to desired motor settings by inserting intermediate motorsettings as necessitated by nest dynamics to ensure that motion stays ina desirable range during transition. If the desired system speed is lessthan “full,” then a signal is sent to adjust the desired motor commandsin proportion to the desired system speed. “Full” is the fully-onposition of the knob, and means that infant calming/sleep-aid device 10,100 is not being limited by this knob and is allowed to perform all ofthe motions it determines to be relevant. If speed control knob 121 isturned down from “full,” motions of infant calming/sleep-aid device 10,100 start to become constrained, so speed control knob 121 acts as anoperator to override the normal motion behavior of infantcalming/sleep-aid device 10, 100. If not, then a comparison is made asto whether the observed motion is nominal. If it is not, then motoroutput is disabled. If it is nominal, then an output signal of desiredmotor commands is given to target motor positions and speeds of theactuator of the multichannel USB motor controller. In some embodiments,sound is delivered to an infant but not motion if an infant is in thedevice but not securely attached. The level of motion and or soundoutput may also be modified by the parents' choice of a special boostfunction.

In an alternative embodiment of motion generation module 128, shown inFIG. 16, there is no receipt by the module of signals related to motionfrequency and amplitude. Therefore, it is only necessary to set desiredmotor commands by interpolating from a current command based on a lookup table of motor commands based on a desired motion state in responseto receiving a signal with respect to the desired motion state. All ofthe other components of motion generation are the same as represented inFIG. 15.

In one embodiment, the motion generation module 128 receives a motionstate input of an abnormal signal, for example that an infant is notbreathing, from the biometric sensor module 1002 (FIG. 10). Theresultant programmed vigorous motion may continue until the abnormalbiometric signal is discontinued, for example when an infant beginsbreathing again, or the device is shut off.

Another exemplary embodiment of an infant calming device is shown inFIGS. 17-21. In this example, the infant calming device includes a mainmoving platform with an integral head support portion, that is, the headsupport portion is contiguous with and rigidly fixed to the main movingplatform, in essence creating a single platform supporting the head andbody of the infant.

An enclosure 1702 for an infant calming device using a single mainmoving platform is shown in FIG. 17. Single main moving platform 2102and rigid base 2114 of this device are shown in FIGS. 18 and 19, whereFIG. 19 also shows the other components of the device, as seen lookingthrough main moving platform 2102. FIG. 20 shows cross sectional viewsof the embodiment of an infant calming device using a single main movingplatform.

As shown in FIG. 21, main moving platform 2102 is supported by mainsupport shaft at main rotation bearing 2106. The main rotation bearing2106 may be comprised of several vertical pieces of plastic or springsteel that do the job of supporting the upper surface, while alsoflexing to replace the springs and dampers described above.

Motion sensing device 2108, such as an accelerometer, underneath mainplatform 2102 detects motion of main platform 2102. Microphones (notshown) detect sound emitted by the infant (not shown) when supported byinfant aid sleep device. Speakers 2110, supported by brackets 2112mounted on rigid base 2114, may be located directly beneath headposition of infant on main moving platform 2102. Secure sleep sackfastening clips may be attached to main moving platform 2102 forsecuring an infant in suitable swaddling clothes.

The exemplary embodiment shown in FIGS. 17-21 operates similarly to theembodiment shown in FIGS. 1-16, described above. The embodiment in FIGS.17-21 differs from that shown in FIGS. 1-16 in that the separate headand body boards are replaced by a single moving board. Along with thereplacement of the separate head and body boards by a single movingboard, the secure sleep sack fastening straps are replaced by clipsintegral to the baby swaddle wrap. The head rotation bearing, rotatinghead platform, head board support U bracket, head balancing extensionspring, and weight sensors are also absent.

In embodiments, the main moving platform 16, 2102 may hang from theframing that is above the main moving platform via fabric and/or cables.The main moving platform 16, 2102 would then be free to rotate or swingas needed. A motor and offset wheel would deliver the needed input tocreate the desired motion, such as a smooth sinusoidal motion of themain moving platform at low frequencies and the rapid acceleratingmotion at high frequencies.

As discussed above, two versions of the infant calming/sleep-aid deviceare shown in FIGS. 2 through 9, with microphones to detect infantcrying, motion and sound actuators, a swaddling system to keep the babyin optimal position and a gel pad to reduce the pressure on the back ofthe skull (thereby avoiding possible plagiocephaly). The device also maycontain a logic board to accomplish two tasks; delivering stagedinterventions of specially engineered sound and delivering motioncreated by two linked platforms attached to a motor and rod actuator (aswell as a series of springs and dampeners to modulate the activity.)These platforms may act in a reciprocating manner about an axis thatintersects the infant and is orthogonal to a major plane of the surfacesupporting the infant to provide a motion that varies from slow smoothrocking (0.5-1.5 cps) to keep babies calm- and promote sleep, andramping up to a faster, smaller, jiggling motion (2-4.5 cps) with a morespiked waveform to deliver a sufficiently abruptacceleration-deceleration action to stimulate the vestibular mechanismof the inner ear, trigger a calming reflex and soothe the baby, such aswhen the baby cries (e.g., head rocking back and forth in excursions ofless than Γ). The sound in the device may be adapted to respond to thebaby's upset by starting a specially engineered high pitched sound, thenstepping down to quieter, lower pitched white noise over severalminutes. A wide variety of sound patterns may be enabled. The device maybe adapted to gradually increase the intensity of the sound and/ormotion during the early weeks of life and to gradually reduce (i.e.wean) the intensity of the sound and/or motion over a suitable timeperiod, such as several weeks or several months later in infancy.

Another exemplary embodiment of an infant calming/sleep-aid device isshown in FIGS. 22 through 27.

As shown in FIG. 22, infant calming/sleep-aid device 2258 may includevarious control system related components including a software controlsystem 2216 for receiving and processing inputs 2200 and generatingoutputs 2246, a user interface 2204, and a communication facility 2214.Components of the software control system and the user interface can belocated on-board or remotely from the enclosure/platform portion ofinfant calming/sleep-aid device 2258. Inputs 2200 may include data orcontrol signals from various types of sensors or devices such asmicrophone or sound sensor 2202, motion control sensor 2206,accelerometer or motion sensor 2208, user interface 2204, biometricsensor, and the like. Outputs from the control system 2216 are directedto devices such as speakers 2248 for controlling the generation ofsound, motion controller 2250 for controlling the motion of a platformor structure on which the infant is placed, Wi-Fi phone call toemergency services, and status light facility 2252 for controllingillumination of various status lights.

Other inputs may also be provided by other sensors such as visualsensors, including cameras, pressure sensors, sensors located in aswaddle or sleep sack, third party sensors, including monitors, sensorsembedded in fabrics, and the like. Sensors embedded in fabrics may beflexible sensors. Sensors may be used for detecting child physiologicalparameters. Sensors may be used to provide inputs and feedback for modeselection for a mechanism that activates the calming reflex of an infantor, in certain circumstances, increases a baby's arousal. Microphone orsound sensor 2202 may be in communication with user interface 2204.Motion control sensor 2206 may be controlled by user interface 2204.Motion control sensor 2206 may be in communication with motiongeneration module 2232. Motion control sensor 2206 may send desiredsystem speed input 2220 to motion generation module 2232.

User interface 2204 may be in communication with inputs such asmicrophone or sound sensors 2202, crying detection module 2218, motionanalysis module 2222, accelerometer or motion sensor 2208, and the like.User interface 2204 may allow a user to input data such as the date ofbirth of an infant, the due date of an infant, the name of the infant,the weight of the infant, and the like. The weight of the infant may beinput manually or automatically. The weight of the infant may be inputautomatically from a scale that is integrated with the infantcalming/sleep-aid device 2258. The user interface 2204 may be used toprovide a diary. The diary may be a sleep diary, cry diary, and thelike. The user interface 2204 may be used to boost baseline stimulationby providing more motion and sound. For example, an extra fast and/orstrong sound could be provided for infants that are difficult to calm.This extra fast and/or strong sound could be called Intervention4.Intervention4 may only be able to be activated two consecutive times,until the device is reset. Intervention4 may be limited to about twominutes of operation. The infant calming/sleep aid device may turn offafter Intervention4 has been operating for about two minutes.

User interface 2204 may be an integral part of the infantcalming/sleep-aid device 2258, or a separate piece, such as on a mobileperipheral device, which may be connected by a wired connection, awireless connection, and the like to the infant calming/sleep aid device2258. The wireless connection may be a Wi-Fi connection, Bluetoothconnection, and the like.

The user interface 2204 may have controls, set-up information input, andother input data that can be sent to the software control system of thedevice. Controls may include an on/off control, sound control, motioncontrol, light control, and the like. Controls may be enabled ordisabled. Motion control may have an extension option that automaticallyextends the sound, extends the basic motion of the device, and the like.The option that extends the basic motion of the device may be used afteran infant is older than four months. Light control may have a dimoption, be used to turn and LED alarm light on or off, and the like.

The user interface 2204 may allow a user to input set-up information,other information, and the like. Set-up information may include duedate, birthdate, name, nickname, date/time setup, and the like. Otherinput information may include information related to shots the infanthas had, feedings, travel, dirty diapers, and the like.

The user interface 2204 may provide various functions, such as Session,Session ‘Super’, History, Profile, Settings, Customization, Journalingand the like. Session may include start/stop session, track sessionduration, track cry and sleep duration, track mode position, sessionsummary, period summary, track epic position, contextual and expert tipsmessaging, alert messaging, AM/PM model, night light, and the like.Period summary may be for a 12 hour clock or 24 hour clock setup.Session ‘Super” may include track mode position, track mode duration,volume control, editable mode position, and the like. History mayinclude compare periods, display AM vs. PM sessions, share data and epicposition via email and social, add sleep note to session, add weightnote to session, and the like. Compare periods may compare periods overa 12 hour period, a 24 hour period, and the like. Profile may includename/nickname, due date, birth date, and the like. Settings may includeoverview, getting started, sleep library, level 4 on/off, notifications,push start, milestones, sleep facts, social network setup, sync on/off,and the like. Customization may include editable session data, manualentry, sound on/off, customize sound, customize mode, show weight inprofile, allow weight input via external API, light control, and thelike. Overview may include content from Epic Education, and the like.Getting Started may include content from First Use Coaching, and thelike. Sleep library may include content from eBooks, and the like.

The user interface 2204 may provide cloud based functions. Cloud basedfunctions may include account management, the ability to invite otheraccount holders to manage profile, add friends, compare session datawith friends, anonymously post to world data, comparesession/period/epic with world data, social commenting, web view ofdata, and the like.

FIGS. 26a-26d illustrate a user interface 2204 in exemplary andnon-limiting embodiments. FIG. 26a illustrates layers of the userinterface 2204. Layers include the shape which represents the top viewof the infant calming/sleep-aid device 2258. Layers may also includeicons. Icons may include a baby icon, a baseline indicator icon, and thelike. Icons may be placed at the center of the display. Layers mayinclude views. Views may include before session 2600, during session2602, end of session 2604, history 2606, and the like. Before session2600 may include a center dot that represents the child. The center dotmay be color coded with color codes. Color codes may include purple forpause, yellow for fuss, cyan for sleeping, and the like. During session2602 may include a ring. A ring may represent levels of wiggle/sound.Center may be baseline. Color may move out as intensity increases. Endof session 2604 may include color. Color may represent an average of thelevels of wiggle/sound used during the session. History may showduration of sleep and fuss as a line chart.

FIG. 26b illustrates sliders of the user interface. Sliders may includea focus on the current state of the infant calming/sleep-aid device2258. Sliders may include a marker. The marker may indicate the currentlevel of motion and sound of the infant calming/sleep-aid device 2258.Sliders may include views. Views may include session start 2608, duringsession 2610, end of session 2612, history 2606, and the like. Sessionstart 2608 may include a marker that represents the infantcalming/sleep-aid device 2258. The marker may be color coded with colorcodes. Color codes may include purple for pause, green for highintervention, cyan for baseline, and the like. During session 2610 mayinclude a marker. The color and position of the marker may showintervention levels. During session 2610 may include a notch. The notchmay indicate the baby. The notch may be color coded with color codes.Color codes may be yellow to indicate fuss, cyan to indicate sleeping,and the like. End of session 2612 may be a heat map that represents anaverage of the intervention levels used during the session.

FIG. 26c illustrates blossoms of the user interface. Blossoms mayinclude an icon for the infant at the center of the experience whiledifferent intervention levels of the infant calming/sleep-aid device2258 are shown in a trajectory around it. Blossoms may include views.Views may include session start 2616, during session 2618, end ofsession 2620, history 2606, and the like. Session start 2608 may includea center dot that represents the infant. The dot may be color coded withcolor codes. Color codes may include purple for pause, yellow for fuss,cyan for sleeping, and the like. During session 2618 may include petals.Each petal may represent levels of motion and sound. The bottom petalmay be baseline, the top petal may be the highest level of intensity,and the like. End of session 2620 may include a heat map. The heat mapmay represent an average of the levels of motion and sound used duringthe session.

FIG. 26d illustrates additional views of the user interface. Additionalviews may include menu/profile 2624, session 2626, end of session 2628,session control 2630, session tip 2632, setup 2634, overview 2636,history 2638, history zoom 2640, history compare 2644, history filter,2646, history tag 2648, and the like. A user may move from one screen tothe next, such as by swiping, such that a user may swipe to see a dayview, swipe again to see a week view, etc.

FIG. 27 illustrates additional views of a user interface of a mobiledevice for use with the infant calming/sleep aid device.

User interface 2204 may be provided as a mobile application. The mobileapplication may provide data inputs to the control mechanism of theinfant calming/sleep aid device 2258. Data may include monitoring data,feedback data, control data, reporting data, analytics data, and thelike. The mobile application may be installed on a mobile device. Thedevice may be a smartphone, tablet computer, and the like. The mobiledevice may have an operating system that may be iOS, Android, and thelike. The mobile application may enable interactions with the device.Interactions may be enabled through a communication interface. Thecommunication interface may be a universal serial bus (USB) interface,Wi-Fi interface, Bluetooth interface, and the like. Interactions may becontrol interactions. Control interactions may be similar to theinteractions that may be enabled directly from the infant calming/sleepaid device 2258, only available on the mobile application, and the like.Examples of control interactions may include the ability to turn onIntervention4 using four fast taps of the on/off button within twoseconds, turn on/off the infant calming/sleep aid device 2258 bypressing and holding the on/off button for three seconds, and the like.

Other mobile device interactions may include reports and statistics,sharing and group interactions, benchmarking and comparisoninteractions, graphic interactions, acoustic signature of a cryinteractions, data upload to a third party interactions, feedback from asubject matter expert interactions, warning alert interactions, overtonecustomization of white noise interactions, other input interactions,journal sharing/printout interactions, weight interactions,breastfeeding interactions, camera interactions, and the like. Otherinput interactions may include photo input interactions, video inputinteractions, audio input interactions, and the like.

Additional inputs may include information inputs. Information inputs mayinclude baby weights, baby lengths, baby circumferences, frequencies,travel, immunizations, illness, heart rate, respiratory rate, bloodoxygenation, and the like. Baby weights may include weight at birth,baby weights at different weighings, and the like. Baby length mayinclude baby length at birth, baby length at different measurings, andthe like. Baby circumference may include baby circumference of the headat birth, baby circumference of the head at different measurings, andthe like. Frequencies may include frequency of feeding, frequency ofdiaper changes/pee or poop, and the like. Information inputs may beadded to a mobile device journal.

Microphone or sound sensor 2202 may send audio data 2210 to cryingdetection module 2218. Accelerometer or motion sensor 2208 may sendmotion data 2212 to motion analysis module 2222. Communication facility2214 may be used to establish communication between inputs 2200 andsoftware control system 2216. Communication may be established viadirect control, remote control, and the like. Direct control may includeproviding control inputs to the communication facility from inputdevices directly integrated with the infant calming/sleep-aid device2258. Remote control may include providing control inputs to thecommunication facility from input devices remotely connected to theinfant calming/sleep-aid device 2258. Remote connectivity may includewired and wireless connectivity. Wireless connectivity may include Wi-Ficonnectivity, Bluetooth connectivity, and the like. Journaling mayinclude track feedings, track diapers, and the like.

Software control system 2216 may include modules. Modules may includecrying detection module 2218, behavior state module 2230, biometricdetection module, audio generation module 2238, motion generation module2232, motion analysis module 2222, status light module 2234, and thelike. Crying detection module may be in communication with microphone orsound sensor 2202, motion control sensor 2206, behavior state module2230, and the like. Crying detection module 2218 may send an infantcrying/not crying status input 2224 to behavior state module 2230.Biometric detection module may be in communication with motiongeneration module 2232, audio generation module 2238, and the like.Biometric detection module may send desired motion state input 2260 tomotion generation module 2232, desired audio track, desiredvolume/equalizer settings input 2236 to audio generation module 2238,and the like. Behavior state module 2230 may be in communication withcrying detection module 2218, motion generation module 2232, audiogeneration module 2238, and the like. Behavior state module may senddesired motion state input 2260 to motion generation module 2232,desired audio track, desired volume/equalizer settings input 2236 toaudio generation module 2238, and the like. Motion generation module2232 may be in communication with behavior state module 2230, motioncontrol sensor 2206, user interface 2204, motion analysis module 2222,motion controller 2250, and the like. Motion analysis module 2222 may bein communication with accelerometer or motion sensor 2203, userinterface 2204, motion generation module 2232, status light module 2234,and the like. Motion analysis module 222 may send motionfrequency/amplitude and motion is safe/is not safe input 2226 to motiongeneration module 2232. Motion analysis module 2222 may send motion issafe/not safe input and motion is soothing/is not soothing input 2228 tostatus light module 2234. Motion generation module may send target motorpositions/speeds input to motion controller 2250 and the like. Audiogeneration module 130 may be in communication with behavior state module2230 speaker 2248, and the like. Audio generation module 2238 may sendaudio generation module input to speaker 2248. Status light module 2234may be in communication with motion analysis module 2222 status lightscolor display facility 2252 and the like. Status light module 2234 maysend target status light colors input 2244 to status lights colordisplay facility 2252 and the like.

Software control system 2216 may also be in communication with datastorage facility 2254, rules engine 2256, and the like. Data storagefacility 2254 may store information that may be accessed by othermodules of the software control system, and the like. Rules engine 2256may provide rules for inputs and triggers to a mechanism to activate the“calming reflex” of an infant.

FIGS. 23a and 23b illustrate the infant calming/sleep aid device 2258 inexemplary and non-limiting embodiments. FIG. 23a is a partially cut-awayperspective view of the infant calming/sleep aid device 2258. FIG. 23bis an exploded perspective view that illustrates components of theinfant calming/sleep aid device 2258. Components of the infantcalming/sleep aid device 2258 may include outer fabric 2300, structure2302, inner fabric/mattress cover 2304, mattress 2306, lower wall 2308,veneer/felt cosmetic layer 2310, stand 2312, and foot pad/wheel 2314.The height of the infant calming/sleep aid device 2258 may beadjustable. FIGS. 23c and 23d are perspective views of the infantcalming/sleep aid device 2258 in a low position 2316 and in a highposition 2318. FIG. 23e illustrates a bottom view of the infantcalming/sleep aid device 2258 with legs attached to the bottom of theinfant calming/sleep aid device 2258. FIGS. 23f-23h illustrate legconnectors 2322 used to attach the legs 2320 to the infant calming/sleepaid device 2258. The legs may be unsnapped and reversed to allow a highor low position of the platform/structure on which the infant issecured.

Infant calming/sleep aid device 2258 may provide a mechanism to activatethe calming reflex of an infant, such as via the control systemdescribed with respect to FIG. 22. The mechanism may use stereotypicalsensory input, stereotypical behavioral output, and the like to triggerthe calming reflex. The activation mechanism may be programmed to waneafter 3-5 months or the like. The mechanism may exhibit thresholdvariations that vary between higher and lower thresholds based on theindividual infant. The mechanism may vary by biometric evaluation orstate of the infant and may call for higher or lower levels ofstimulation based on the state of the infant. The state may be a quietsleeping state, active sleep state, drowsiness state, quiet alert state,fussing state, crying state, and the like. The state may be matched tothe optimal stimulus level of an individual infant. Levels may also beadjusted to match the age of the infant, for example during the firstmonth of the life of the infant. Failure to exceed the optimal stimuluslevel may result in an absence of response by the infant to themechanism. The mechanism may be activated by sound generated by theinfant, movement generated by the infant, abnormal biometric signals,and the like. The output of the mechanism may cause reductions in motoroutput levels. The infant calming/sleep aid device 2258 mayautomatically shut down if an infant is not calmed by higher levels ofmotion and sound. Higher levels of motion and sound may be calledIntervention3 and Intervention4. The infant calming/sleep aid device mayteach infants to sleep better by training the sleep pattern of theinfant using sleep cues. Sleep cues may be swaddling, effective motion,optimal sound, and the like. Motion may take on characteristics of amore square-shaped wave as the platform moves more quickly.

The mechanism to activate the calming reflex or the conditioned responseof an infant may be activated by a feedback based control mechanism. Thefeedback based control mechanism may select modes, parameters, parameterranges, and the like. Modes may be motion modes, sound modes, and thelike. Parameters may be motion parameters, sound parameters and thelike. Parameter ranges may be motion parameter ranges, sound parameterranges, and the like. The feedback based control mechanism may providemotion feedback to control the motion of the swing of the infantcalming/sleep aid device 2258. The motion feedback may activate acalming reflex of the infant to provide vestibular stimulation in theinner ear of the infant. The feedback based control mechanism mayoperate as a feedback loop. The feedback loop may result in a reductionovertime of the mechanism to activate the calming reflex or conditionedresponse of an infant. For example, it may be desirable to wean aninfant from the motion of the infant calming/sleep aid device 2258starting when the infant is of the age 3-4 months. The feedback basedcontrol mechanism may be activated by a remote control, a camera mountedon the infant calming/sleep aid device 2258, and the like. The remotecontrol may be operated by a parent. The parent may be in the same roomas the infant calming/sleep aid device 2258, or a different room thanthe infant calming/sleep aid device 2258.

The infant calming/sleep aid device 2258 may provide analytics andalgorithms. The analytics and algorithms may be based on readings frommicrophone, sensors and the like. The analytics and algorithms mayprovide feedback input to the mechanism to activate the calming reflexof an infant. The algorithms may analyze combinations, storecombinations, replicate combinations and the like. Sensors may providesensor readings. Sensor readings may have ranges. A range may be a soundrange, a motion range, and the like. A sound range may be based on theblood flow/heartbeat of a mother. The heartbeat may be 80 bpm, 160 bpm,240 bpm, and the like. The motion range may be between 0.5-4.25 Hz.

The analytics and algorithms may be used to detect if an infant is upsetor has apnea. The detection may be based on visual inspection,continuous detection, and the like. Visual inspection may be used toinitiate a calming mechanism involving a relatively step wise and highfrequency motion. Continuous detection may shift into a remain calmprotocol, may use a sensor, and the like. A sensor may detect if theinfant is in the infant calming/sleep aid device 2258, detect if thesecure sleep sack is properly attached to the infant calming/sleep aiddevice 2258 and the like. The mechanism may only turn on if the sensordetects that the sleep sack is properly installed in the infantcalming/sleep aid device 2258.

The infant calming/sleep aid device 2258 may provide an applicationprogramming interface (API). The API may allow integration of the infantcalming/sleep aid device 2258 with external devices and system. Externaldevices and systems may provide additional control inputs to activatethe mechanism to activate the calming reflex or conditioned response ofan infant. The mechanism to activate these infant responses may provideinputs to the external devices and systems. Control inputs may includesound control inputs. Sound control inputs may be used to turn on andoff external sound sources, turn on and off sound sources internal tothe infant calming/sleep-aid device mechanism, and the like. The soundcontrol inputs may provide the user the ability to choose which soundsources to activate and even to introduce their own novel sounds, suchas a recording of a parent's voice. Integration may be by wired orwireless connectivity. Wired connectivity may include the use of ahard-wired splitter. Wireless connectivity may include Wi-Ficonnectivity, blue-tooth connectivity, and the like. External devicesand systems may be home automation network external devices and systemsand allow integration of the infant calming/sleep-aid device 2258 with ahome automation network. Integration with the home automation networkmay enable the infant calming/sleep-aid device 2258 to report to a useror allow the user to remotely control the infant calming/sleep-aiddevice 2258. Integration may include integration with monitors. Monitorsmay include carbon monoxide monitors, oxygen level monitors, breathingmonitor, oxygen saturation monitors, motion monitors, temperaturemonitors, smoke monitors, heart rate detector monitors, respiratory ratemonitors, and the like. Monitors may provide an input to activate theinfant calming/sleep-aid device 2258 that may activate the infantcalming/sleep-aid device 2258. The infant calming/sleep aid device 2258may be activated to attempt to wake an infant, such as by stimulationwith vigorous motion or loud sound or both. An infant may be stimulatedto prevent sudden infant death syndrome (SIDS). Integration may alsoinclude integration with safety systems. Safety systems may include homesafety systems, infant safety systems, child safety systems, and thelike.

The infant calming/sleep-aid device may also include collapsible wallsand legs, handles, cord, wheels, and the like. Collapsible walls mayenable portability and adjustability. Portability may include ease ofmoving the infant calming/sleep-aid device around a room, facilitateshipping, travel, aging of the baby, a standing position, user orstroller height, and the like. Cord may be a retractable cord, abreak-away cord, and the like. Wheels may be implemented when collapsed,and the like. Legs may be extendable, telescoping, collapsible orremovable and rotated/reinserted to be a different height, and the like.The infant calming/sleep-aid device 2258 may be made available in alightweight embodiment, include a stand trolley, and the like. Standtrolley may include wheels for inside transport, make the infantcalming/sleep-aid device 2258 reconfigurable into a stroller, providestability, motor removal, enable transportability, and the like.Stability may include stability during motion, stability duringstrolling, and the like. The infant calming/sleep-aid device 2258 may bemade available in a variety of colors and color combinations. Color andcolor combinations may be user selectable and may be changeable viaalternative veneers, alternate ornamental fabric decoration strips, meshcolor/design, sleep sack color/design, and the like. The infantcalming/sleep-aid device 2258 may be made available in organicmaterials, appealing designs, and the like. The infant calming/sleep-aiddevice 2258 may be certified for safety, certified for safety in manycategories, and the like. The infant calming/sleep-aid device 2258 mayhave removable mesh that allows for creating individually selecteddesigns printed on the outside mesh. The accelerometer 2223 of theinfant calming/sleep-aid device may measure head excursions to preventexcessive motion, and the like. The infant calming/sleep-aid device 2258may be made include flexible mesh. Flexible mesh may provide betterairflow and allow broader excursions of the main moving platform 16. Theflexible mesh must be made stiff enough to prevent a pocket forming topotentially suffocate an infant who rolls into it, however flexibleenough to allow for give so the top platform may sway back and forth.

A mattress may include a gel pad on which the head of the infant mayrest. A weight sensor may be underneath the gel pad. The infantcalming/sleep-aid device 2258 may not activate or may shut off if theweight sensor under the gel pad does not indicate that the head of theinfant is resting on the gel pad.

The infant calming/sleep-aid device 2258 may include a sleep sack thatmay have an attachment. The attachment may attach the sleep sack to amain moving platform. FIG. 24a illustrates an illustrative andnon-limiting embodiment of the attachment. FIG. 24b illustrates anexemplary and non-limiting embodiment of the infant calming/sleep-aiddevice 2258 with an attachment mechanism 2402. Attachment mechanism 2402may secure the sleep sack to the infant calming/sleep-aid device 2258.Attachment may be via a one-handed attachment mechanism, and the like.Infant calming/sleep-aid device 2258 may not switch on if the sleep sackis not properly secured to the infant calming/sleep-aid device 2258. Inthis regard, FIG. 28 illustrates an exemplary embodiment of a clip fordetecting if an infant is properly secured, in order to controloperation of the device. In embodiments, two clips may act to sense whenattachment pieces of a sleeping sack are in place to indicate that aninfant is securely fastened on a support surface of the infantcalming/sleep aid device. Various control modes can follow. For example,motion of the device may be prohibited/disabled if an infant is notproperly secured while allowing sound to still be generated. Othersensors are also envisioned for detecting if an infant is properlysecured, such as a contact switch, or optical switch, or the like, suchas shown in FIG. 29. For example, safety clips that the secure sleepsack attaches to may contain a switch that enables the motion mechanism.Failure to properly attach the secure sleep sack will result in thedevice delivering sound, but no motion when it is turned on. Motion willonly be delivered if the secure sleep sack is properly attached on eachclip.

The location of the sleep sack attachment may be adjustable. Forexample, the location of the sleep sack attachment may be adjustable bytwo to three inches or so.

The sleep sack may allow enough room in the sack for the hips of theinfant to flex and open. The sleep sack may keep the arms of the infantat the sides of the infant. An internal band may be used to keep thearms of the infant at the sides of the infant. The secure sleep sack mayhave arm openings. Arm openings may be opened or closed. The sleep sackmay have a zipper closure. The zipper may open in an upwards direction,a downwards direction, and the like. The sleep sack may have anadjustable area on the back. The sleep sack may have a narrow sleeve orlight elastic at the end of the sleep sack wing, on the clip attached tothe infant calming/sleep-aid device 2258, and the like.

The sleep sack may be available in different designs. Designs may beprinted designs. Printed designs may be non-threatening designs.Non-threatening designs may be animal designs, angel designs, wings, andthe like. Designs may be available with options, changeable, engaging,and the like. The sleep sack may be available in various materials.Materials may include a mesh component, be adapted for the seasons, andthe like. A mesh component may be a cooling component, a breathablecomponent, and the like. Mesh may prevent overheating and reduces therisk of suffocation. The breathable component may include active airflowto increase breathability. Adaptability for the seasons may includeadaptability for warm temperatures, cold temperatures, and the like. Thesleep sack may include interior sleeves.

FIGS. 25a-25j illustrate a sleep sack according to illustrative andnon-limiting embodiments. FIG. 25a illustrates a front view of the sleepsack in a closed position with an infant inside of the sleep sack. FIG.25b illustrates a front view of the sleep sack in an open position withan infant inside the sleep sack. FIG. 25c illustrates a back view of thesleep sack with an infant inside the sleep sack. FIGS. 25d-25eillustrate front views of the sleep sack in a closed position. FIG. 25hillustrates an infant in the sleep sack and the sleep sack attached tothe main moving platform 16. FIG. 25i illustrates a front view of thesleep sack. FIG. 25j illustrates a rear view of the sleep sack.

The infant calming/sleep-aid device 158 may have selectable modes.Selectable modes may be selected with an algorithm. The algorithm setpoint may be based on the age of the infant. The infantcalming/sleep-aid device 158 may ask for dates of the infant from auser. Dates of the infant may be due date, birth date, and the like. Theinfant calming/sleep-aid device may ask the user if the infant was bornearly, late, and the like. Age of the infant may be based on the ageinputs. Age inputs may be dates of the infant, if the infant was born,early, late, and the like. Algorithm set point may be calculated byasking the age of the infant, then subtracting the age of the infantfrom the birth date of the infant. Algorithm set point may also becalculated by setting the birth date of the infant to the due date ofthe infant. Age of the infant may be provided in months, weeks, days,and the like.

The infant calming/sleep-aid device 158 may have a start mode. Startmode may be initiated when the infant calming/sleep-aid device 158 isturned on to operate and may be based on the age of the infant. Startmode for an infant less than 0 months old may be Baseline and may not gohigher than Intervention2. Start mode for an infant that is between 0and 0.5 months may be Initial1 and may not go higher than Intervention2.Start mode for an infant that is between 0.5 and 3 months may beInitial1. Start mode for an infant between 3 and 4 months may beBaseline or Initial1 if Baseline Boost is active. Start mode for aninfant that is older than 4 months may be initial 1 with 1.0 Hz motionand may then use no motion and normal sound in Baseline. Normal soundmay be 68 dB Rain on the Roof.

Selectable modes may be modified by a Baseline Boost setting. BaselineBoost setting may be based on the age of the infant. Baseline boost foran infant that is younger than 0 months may not be activated. BaselineBoost setting for an infant that is between 0 and 1 month may cause theinfant calming/sleep-ad device 158 to start in Initial1 when switched onand may use Initial1 settings in Baseline. Baseline Boost setting for aninfant that is between 1 and 3 months may cause the infantcalming/sleep-ad device 158 to start with a more robust level of sound,or motion, or both. This level may be equivalent to Initial1 when thedevice is switched on and may use 1.0-2.0 Hz motion and 70 dB soundsettings in Baseline. Baseline Boost setting for an infant that isbetween 3 and 4 months may cause the infant calming/sleep-ad device 158to start in Initial1 with 1.0-2.0 Hz motion setting when switched on andmay then use normal settings in Baseline. Baseline Boost setting for aninfant that older than 4 months may cause the infant calming/sleep-addevice 158 to start in Initial1 with 0.5-1.5 Hz motion when switched onand may use no motion and normal sound settings in Baseline. Normalsound may be 68-74 dB Rain on the Roof sound.

When Baseline Boost is set for an extended setting, it may automaticallyrevert to default after 14 days of activation, immediately, and thelike. Revert to default immediately may occur when the infantcalming/sleep-aid device 158 is reset for a new infant.

Selectable modes may include Baseline, Intervention1, Intervention2,Intervention3, Intervention4, and the like. Baseline mode settings maybe based on the age of the infant. Baseline mode settings for an infantbetween 0 and 1 month may be 1.0 Hz motion and Rain on the Roof at 70 dBsound, for an infant between 1 and 4 months 1.0 Hz motion and Rain ofthe Roof at 68 dB sound, for an infant older than 4 months 0.0 Hz motionand Rain on the Roof at 68 dB sound, and the like. Baseline whenBaseline Boost is activated for an infant between 0 and 1 month may be2.0 Hz motion and Rain on the Roof at 72 dB sound, for an infant between1 and 3 months 2.0 Hz motion and 70 dB Rain on the Roof sound, and thelike. Baseline may step up to Intervention1 if Crying_D1 is detected.Crying_D1 may trigger at 0.6 accumulated seconds of Crying AudioClassification time during a period of 6 seconds, and the like.

Intervention1 may be 2.5 Hz motion and Rain on the Roof at 72 dB sound.Intervention1 may step up to Intervention2 if Crying_D1 is detected,otherwise go to CoolDown3 after 8 minutes.

Intervention2 settings may be based on the age of the infant.Intervention2 settings for an infant younger than 0.5 months may be 2.8Hz motion and Strong Hair Drier sound at 75 dB, may switch to Timeout ifCrying_D2 is detected in the last 10 seconds (3:50 to 4:00), otherwisestep to CoolDown2 after 4 minutes, and the like. Crying_D2 may triggerat 1.2 accumulated seconds of Crying Audio Classification time in aperiod of 6 seconds, and the like.

Intervention2 settings for an infant between 0.5 and 1 month may be 2.8Hz motion and Strong Hair Drier sound at 75 dB, may step up toIntervention3 if Crying_D2 is detected, otherwise go to CoolDown2 after4 minutes, and the like. Intervention2 settings for an infant older than1 month may be 3.0 Hz motion and Strong Hair Drier sound at 75 dB, maystep up to Intervention3 if Crying_D2 is detected, otherwise go toCoolDown2 after 4 minutes, and the like.

Intervention3 settings may be based on the age of the infant.Intervention3 settings for an infant between 0.5 and 1 month may be 2.8Hz motion and Fast and Vigorous sound at 79 dB, and the like.Intervention3 settings for an infant older than 1 month may be 3.25 Hzmotion and Fast and Vigorous sound at 79 dB, may switch to Timeout ifCrying_D2 is detected in last 10 seconds (2:20 to 2:30), present useroption to use Intervention4, otherwise Step to CoolDown1 after 2.5minutes, and the like. CoolDown1 settings may be based on the age of theinfant. CoolDown1 settings for an infant between 0.5 and 1 month may be2.8 Hz motion, Strong Hair Drier 75 dB sound, for an infant older than 1month 3.0 Hz motion and Strong Hair Drier 75 dB sound, and the like.CoolDown1 may step up to Intervention3 if Crying_D2 is detected,otherwise go to CoolDown2 after 4 minutes, and the like. CoolDown2 maybe 2.5 Hz motion and Strong Hair Drier sound at 72 dB and the like.CoolDown2 may step up to Intervention2 if Crying_D2 is detected,otherwise go to CoolDown3 after 8 minutes, and the like. CoolDown3settings may be 1.8 Hz, Rain on the Roof sound at 70 dB, and the like.CoolDown3 may step up to Intervention1 if Crying_D2 is detected,otherwise got to Baseline after 12 minutes, and the like.

Intervention4 may be only manually activated. Intervention4 settings maybe based on the age of an infant. Intervention4 settings for an infantbetween 0.5 and 1 month of age may be 2.8 Hz Fast and Vigorous at 81 dBsound, for an infant older than 1 month 3.25 Hz Fast and Vigorous soundat 85 dB, and the like. Intervention4 may switch to Timeout if Crying_D2in last 10 seconds (1:50 to 2:00) is detected, otherwise return toregular operation by auto-stepping to Intervention3 after 2 minutes, andthe like.

Timeout may be no alarm, alarm noise then silence, and the like. Alarmnoise may be 6 beeps with 1 second timing between beeps, 4 second pause,3 beeps with 1 second timing between the beeps, and the like. Timeoutmay also include an LED. LED may be a red LED, flashing until the infantcalming/sleep-aid device 158 is reset by the user, and the like.

The infant calming/sleep-aid device 2258 may include other safetymechanisms that may impact the selection and activation of theoperational modes. Other safety mechanisms that may impact the selectionand activation of the operational modes may include shutting off ifIntervention3 has ended and the infant is still crying, shutting off ifIntervention4 has ended and the infant is still crying, not starting ifthe sleep sack is not properly engaged, not starting if the infant'shead is not sensed to be in the proper location, stopping if theinfant's head is sensed to no longer be in the proper location, notstarting if the infant calming/sleep-aid device 2258 has been activatedfor longer than 6 hours in the day for the first two months, may notstart if a sensor detects that the baby is not aligned properly in theinfant calming/sleep-aid device 2258, and the like. If the infantcalming/sleep-aid device 2258 has shut off because either Intervention3or Intervention4 has ended and the infant is still crying, the infantcalming/sleep-aid device 2258 may be reset, in order to allow the infantcalming/sleep-aid device 2258 to be activated again.

The infant calming/sleep-aid device 2258 may include protocols,profiles, components, and add-on's. Protocols may be based on the age ofthe infant and how upset the infant is. Protocols may be based onfunctions. Functions may be motion functions, sound functions, lightindicator functions, ambient light sensor functions, light generationfunctions, or combinations of functions. Light indicator functions maybe a night light, an indicator to provide a warning to a user when theuser is shaking the infant calming/sleep-aid device 2258, an indicatorto signal which intervention levels are being delivered, and the like.The indicator to provide a warning to a user when the user is shakingthe infant calming/sleep-aid device 2258 may indicate that the level ofshaking may be unsafe. Light indicator functions may be integrated withthe infant calming/sleep-aid device 2258, displayed on a connecteddevice, and the like. A connected device may be a smartphone, tabletcomputer, and the like. Ambient light sensor functions may be integratedwith the infant calming/sleep-aid device 2258, located on a connecteddevice, and the like. Light generation functions may be functional,aesthetic, and the like. Functional light generation functions mayilluminate the user interface of the infant calming/sleep-aid device2258, provide an orange melatonin inducing night light, and the like.Profiles may be based on knowledge of an infant profile, user overrideusing preferences, and the like. User override may provide the user withseveral choices to override and raise the baseline intervention.Components may be cords, batteries, motors, and the like. Cords may bebreakaway cords, retractable cords, and the like. Batteries may berechargeable as an option for sound, and the like. Add-on's may becameras, scales, measuring devices, a kit for turning the infantcalming/sleep aid device 2258 into a crib, playpen, or the like, extrablankets, sheets, skins, parts, a travel bag, and the like.

The infant calming/sleep-aid device 2258 may facilitate interfaceintegration. Interface integration may facilitate integration withinterfaces such as Bluetooth interfaces, hard-wired interfaces, homeautomation network interfaces, monitors, and the like. Hard-wiredinterfaces may include hard-wired splitter interfaces. Monitors mayinclude carbon monoxide monitors, safety monitors, and the like. Safetymonitors may include home safety monitors, baby safety monitors, childsafety monitors, and the like.

The infant calming/sleep-aid device 2258 may comprise a user interface.The user interface may comprise a control panel. The control panel maycontrol options such as motor speed, modulation, speaker output, and thelike. The control panel may comprise knobs, switches, lights, motionactivation, sound activation, interfaces to drive electronics and otherI/O methods.

The infant calming/sleep-aid device 2258 may comprise sub-assemblycomponents. Such components may comprise amplitude modulationcomponents, screws, gears, nut frames, springs, and the like.

The infant calming/sleep-aid device 2258 may comprise a head platform.The head platform may passively rotate. The head platform may comprise aspring system using injection molded plastic as the spring/damper toreduce noise and parts required. The head platform may comprise aplurality of dampers. The head platform may comprise a covering. Thecover may be flexible, cloth, foam, or the like. The head platform maycomprise joint connectors, such as, but not limited to, hinge and rodconnectors. The head platform may comprise bearings such as, but notlimited to rotation and head rotation bearings. The head platform maycomprise wraps. The wraps may comprise swaddling wraps, fastening wraps,and the like.

The infant calming/sleep-aid device 2258 may comprise an enclosurearound a sleep surface. One embodiment may have a light meshveil/mosquito netting over the top of the device. One embodiment mayhave an ornamental animal head and tail that may be attached onto thedevice. The sleep surface may comprise a position stabilizer. Thesurface may secure a baby in supine position to prevent unraveling orrolling and to maintain optimal stimulation positioning. The infantcalming/sleep-aid device 2258 may comprise a single head platform whichmay passively rotate and which may be constrained by springs or dampers.The sleep surface body platform made from flexible cloth covering orflexible foam padding. In embodiment, the sleep surface may comprise amovable joint connector using hinges, rods, or the like. In embodiments,the sleep surface may comprise a support platform. In embodiments thesleep surface may comprise bearings. In embodiments, the sleep surfacemay comprise a special head insert to reduce pressure on back of skull.In embodiments, the infant calming/sleep-aid device may compriseadjustable legs allowing variable height configurations. In embodiments,the sleep surface may comprise a secure sleep sack. In embodiments, thesleep surface may interact with an electronically programmable interfacesystem. The interface system may comprise a control panel. The controlpanel may comprise switches, lights, and other I/O interfacecapabilities. The interface system may comprise automated programmingselections or may allow a user to select device settings, such asduration. In embodiments, the sleep surface may comprise driveelectronics to control drive motor speed, an amplitude modulation motor,and speaker audio output. Speaker outputs may comprise specifiedequalizer settings i.e. the use of special sound profiles to promotesleep and reduce crying. In embodiments, the sleep surface may compriseplates such as drive plates or swing arm plates, among others. Inembodiments, the sleep surface may comprise a push or pull rod. Inembodiments, the sleep surface may comprise drive motor connections todifferent drive types such as clamps, bearings, pins, among others. Inembodiments, the sleep surface may comprise an elastic actuator catchbracket. In embodiments, the sleep surface may comprise a sub-assemblyto directly control the amplitude output of the main rotating platform.The sub-assembly may comprise components such as, but not limited to,amplitude modulation rotational bearings, acme screws, acme nuts, acmenut frames, and gears. In embodiments, the sleep surface may comprise anamplitude modulation motor.

The infant calming/sleep-aid device 2258 may comprise a motiongeneration and drive mechanism for a crib. The mechanism may comprise anelectronic motor. The motor may be isolated from proximity to the babyfor EMR shielding. The mechanism's movement may take into account wearand tear. The mechanism may comprise elastic walls to move with themattress. The mechanism may comprise a swing arm crank shaft eitherdirectly or indirectly attached to the motor. The mechanism may comprisea plurality of springs such as injected plastic springs. The mechanismmay have stability components in order to compensate for interactionswith the stand and the environment. The mechanism may move in asinusoidal motion when the infant is asleep and a non-sinusoidal motionwhen the infant is awake or crying, to attempt to calm the child down.The mechanism may operate with a direct amplitude adjustment or mayoperate without such direct adjustments. Direct amplitude adjustmentsettings may comprise a slow and large amplitude setting (e.g. 30 cyclesper minute and 6 cm/cycle at the head), a fast and short amplitudesetting (e.g. 150 cycles per minute and 3 cm/cycle at the head), a rapidand short amplitude setting (e.g. 180 cycles per minute and 2 cm/cycleat the head, among other combinations (e.g. 4.5 Hz, 270 cpm, range150-270 cpm). The mechanism may comprise an accelerometer in order tomeasure head movement. In embodiments, the mechanism may work inconjunction with sensors placed under a mattress to detect when or if aninfant is in the crib without being secured in the sleep sack. Themechanism may stop movement if the sensors detect that the infant is ina compromised position or if the infant is no longer in the sleep sack.Movement may also stop when a calming movement mode has been completedand the infant is still crying. In embodiments, users may not be able tomanually select movements and may warn users if safety parameters arenot met, such as excessive acceleration or unsafe frequency. Inembodiments, a manual override may be provided to uncouple the motiongenerator if a motion is undesirable

The infant calming/sleep-aid device 2258 may comprise a crib soundsystem. In embodiments, equalizer settings may be provided for optimalpitch profiles (e.g. sound levels are mixed with increasing high pitchprofiles as a baby cries more). The sound system may comprise speakersand may generate sounds similar to those hard by the babies in utero.For example, sounds may be generated to replicate the turbulence ofblood flowing through uterine and umbilical arteries. In embodiments,the high frequency component may be diminished (e.g. 65 to 70 dB with aprofile predominantly about <500 Hz). In other embodiments, the systemmay be capable of a harsher sound (e.g. 70 to 75 dB with a profilepredominantly about <1000 Hz) or a multi-frequency sound (e.g. 75 to 80dB with a profile from 0 to 16000 Hz). In embodiments, the system may becalibrated not to exceed 85 dB at the infant's head, not to exceed morethan 18 hours a day to prevent overuse and not to exceed 85 dB forlonger than 20 minutes of an hour. If such levels are exceeded, anotification may be provided to a user in order to stop usage. Inembodiments, the speaker may make an alarm sound when the device timesout. In embodiments, the sound system may comprise variable volumecontrols. In embodiments, the sound system may be able to detect sounds.Such detections may be conducted by microphones to sense warnings, tohear a child, or to indicate the duration a child has been crying, amongother uses. The sound system may be used to conduct analysis on suchdetections. In embodiments, the sound system may be battery operated.Sounds may be imported into sound interface applications, such as DolbyAdvanced Audio v2, to provide music, voices, singing as an overtone, orinteractively talk to the infant via the application API. Inembodiments, the sound system may be removed or dampened.

In embodiments, the infant calming/sleep-aid device 2258 may comprisemicroprocessors for use in the crib. Microprocessors may be used todifferentiate sounds, such as infant sounds, system sounds, or ambientnoise. Microprocessors may be used to record and analyze sounds. Suchsounds may include sounds which reflect a baby's state (e.g. sleeping,crying) or to provide feedback. Microprocessors may be used to generateresponses and deliver the optimal mix of sound and motion for aspecific. For example, a user may implement an initial combination ofsound and motion for the first few uses, then switch to a differentprogram based on a child's reaction to the uses. Microprocessors may beused to respond to changing states, such as to calm crying, reduce sleeplatency, increase sleep efficiency, among others. Microprocessors mayalso be used to wean infants off of motion and sound as they age. Forexample, the device may increase sound and motion as child gets olderand then automatically wean the baby off motion as he or she gets over 4months. The device may also react to incidents of waking and reducedcrying. Microprocessors may take in inputs such as the weight of aninfant, age of infant, whether the infant was delivered on time, theduration of detected sound made by infant, the duration of detectedmotion of infant, the desired motion state, the sensed motion frequency,the amplitude of main platform, the desired system speed, whether motionof main rotating platform exceeds safety threshold, and the like. Themicroprocessor may generate outputs such as motor control, audioresponses and visual signals.

The infant calming/sleep-aid device 2258 may comprise a mechanism forthe more square waveform generation for a crib. Such a mechanism may beenabled by flexible joint connecting head and body platform. The mainrotating platform may use a variety of variables to determine thewaveform generation, such as weight of infant, drive motor frequency,balancing compression spring force constant, as well as other variables.

The infant calming/sleep-aid device 2258 may rely on several algorithmsin order to generate outputs to calm an infant. The device may analyzecertain output combinations that have succeeded, store suchcombinations, and then replicate these combinations. The device maycreate profiles based on knowledge of a child's physiological orbehavioral parameters or based on a parent or user's overrides andpreferences, among a variety of other parameters.

The infant calming/sleep-aid device 2258 may comprise a motion analysismodule. The module may comprise a motion amplitude estimate signal, athreshold-crossing based motion frequency estimator, a time-basedfilter, a digital filter bank, a filtered accelerometer data signal, anda motion frequency estimate signal among others. The infantcalming/sleep-aid device 2258 may comprise a behavior state machinemodule, an audio generation module, a crying detection module, and thelike. The crying detection module may comprise a digital band-passfilter and a time-based filter.

The infant calming/sleep-aid device 2258 may comprise a mattress for acrib. The mattress may be made from organic materials such as organiclatex, coconut fiber, or polyethylene, and may comprise a gel pad forthe head. The mattress may be created for firmness or softnesspreferences, and may also be waterproof. Compatible sheets may be usedfor the mattress and the mattress may contain circuitry so that it maymaintain connectivity with walls, the mattress, and the platform.

The infant calming/sleep-aid device 2258 may be controlled remote bysmartphone or other mobile device using communication standards such asBluetooth. The infant calming/sleep-aid device 2258 may comprisevariable motion and sound capabilities as well as a feedback loop andmechanisms to reduce functionality over time. The infantcalming/sleep-aid device 2258 may comprise a moving platform and mayhave a dual range of motion. The infant calming/sleep-aid device 2258may comprise a plurality of collapsible walls and legs. Suchfunctionality may aid in shipping, travelling, aiding a child to stand,among other uses. The functionality may change depending on the age ofthe infant or the stroller height/height of the baby's mother. Theinfant calming/sleep-aid device 2258 may comprise handles, wheels, andlegs that may be extendable, adjustable, or collapsible. The infantcalming/sleep-aid device 2258 may comprise trolley functionality totransform the device into a stroller or it may comprise a cribfunctionality to transform the device into a crib. The infantcalming/sleep-aid device 2258 may comprise wheels for transport. Theinfant calming/sleep-aid device 2258 may comprise a removable motor. Theinfant calming/sleep-aid device 2258 may comprise flexible and removablemesh components. One embodiment envisions the ability to re-obtain backunits and refurbish them to resell on a secondary market.

In embodiments, the infant calming/sleep-aid device 2258 may generate aplurality of outputs. Such outputs may be user modes such as movementmodes. Movement modes may comprise short and large amplitude modes, fastand short amplitude modes and rapid and short amplitude modes, amongothers. Outputs may also comprise sound modes such as modes where thehigh frequency component is diminished, modes that produce a harshersound and modes that produce a multi-frequency sound.

The infant calming/sleep-aid device 2258 may comprise sensors such as,but not limited to, audio sensors, motion sensors, biometric, a camera,other third party sensors, flexible sensors, accelerometers, a warningsystem, and a manual override. The infant calming/sleep-aid device 2258may comprise certain product add on components such as a camera, ascale, an ambient temperature thermometer, a heart rate monitor, arespiratory rate monitor, an oxygen monitor, a measuring device, a kitfor turning the device into a crib, a kit for turning the device into aplaypen, extra accessories, a microphone, and sound importingcapabilities, such as music, voices, singing, and interactive talkingvia an API. In embodiments, device components may be removable. Theinfant calming/sleep-aid device 2258 may comprise an electrical cordthat may be able to break away or may be retractable. The infantcalming/sleep-aid device 2258 may comprise batteries, and inembodiments, batteries which may be rechargeable. The infantcalming/sleep-aid device 2258 may comprise light indicators such as anight light, or a shaking detection light, ambient light sensors,functional lights (e.g. to light up the user interface, to inducemelatonin, to assess manual jiggle, to function as a stroller light),and lights to signal that an intervention level is being delivered. Theinfant calming/sleep-aid device 2258 may comprise several differentaesthetic features, such as changing designs.

The infant calming/sleep-aid device 2258 may employ a plurality ofdifferent parameters. In embodiments, sound and motion ranges may berestricted. In embodiments, the device may use different thresholds ortriggers to deliver output. Such triggers may include sensory inputs,behavioral inputs, variational inputs, head movement, acceleration,frequency, amplitude, rotation, safety, number of waking incidents,number of crying incidents, abnormal biometric readings and an infant'smeasurements, among others. Variational inputs may include individualvariations, optimal stimulus level data, and state data such as type ofsleep, drowsiness, quietness, fussing, or crying. The infantcalming/sleep-aid device 2258 may rely on duration inputs for sound andmotion. The infant calming/sleep-aid device 2258 may rely on targetinputs such as desired motion state or desired system speed. The infantcalming/sleep-aid device 2258 may rely on noise detection from thesystem, infant, or ambient noise and also rely on biometric sensors. Thedevice may differentiate between multiple types of noise. The infantcalming/sleep-aid device 2258 may rely on filters such as band-pass,digital band-pass, time-based, a filter bank, or a digital filter bank,among others.

The infant calming/sleep-aid device 2258 may comprise materials such asflexible mesh and seasonal materials. Such materials may be warm, light,or breathable depending on the environment in which the device isdeployed.

The infant calming/sleep-aid device 2258 may be deployed for severaluses such as, but not limited to monitoring, reporting, control,analytics, reports/statistics, sharing/groups, benchmarking/comparison,graphics, acoustic signature of the cry, organizational data, expertfeedback, communications (e.g. walkie-talkie), providing alerts (e.g.warning alerts, health concern alerts), overtone customization of thewhite noise, photo/video/audio input, journal sharing/printout,automatize diaper/formula ordering online, weight determination,breastfeeding determination, and image capturing uses, among others.

The infant calming/sleep-aid device 2258 may be integrated to work witha smartphone or other similar mobile device. The device may communicatewith the mobile device using methods such as USB, Bluetooth, and Wi-Fi,among others. The mobile phone may be used to input information such asweight (at birth and longitudinal weight), length (at birth andlongitudinal), head size (at birth and longitudinal), the frequency offeeding, frequency of diaper changes and sleep behavior, among others.User may be able to use their mobile device to instantly create andshare graphic displays of their baby's sleep pattern over differentperiods of time, among many other uses.

Devices of the type depicted in this disclosure were tested in thefollowing way: A baby was placed in a swaddling sack (with arms in orout) attached to the mattress of the device and securely laid on his/herback. The device produced a baseline level of low pitched, rumblingnoise at approximately 65 dB and baseline motion of a smooth,side-to-side rocking (2 inch excursions to either side). When the babycried for more than ˜10 seconds, the device responded by playing aspecially engineered sound that was harsher, higher pitched, moremulti-frequency (75-80 dB) to mimic the intensity of the sound that thebaby heard inside the mother's uterus prenatally. (This sound can bemeasured in situ at up to 92 dB.) If the crying continued another ˜10seconds (despite the sound), the motion accelerated to a faster, morejiggling action of the head (2-3.5 cps, but no more than 1 inch headexcursions to either side). The combination of fast movements deliveredwith sufficient vigor, the harsh, loud sound, and the secure sleep sackall worked together to activate the calming reflex, in the majority ofirritable babies and inducing either calmness or sleep. The deviceresponded to the baby's cry in a step-wise fashion-gradually increasingsound and then motion-to a maximal level. Once the baby was calmed themotion and sound of the device was gradually reduced in a specific,step-wise fashion back to the baseline activity.

Subjects

The device was tested on over twenty babies (12 girls, 10 boys) were inthe device. The babies ranged from 5 weeks to 6 months of age. Theirweights ranged from 8 pounds to 18 pounds.

Methods and Procedures

The subjects were tested to record their resting and sleeping in thedevice. The tests usually began when the baby was hungry and tired(immediately before their usual naptime). The time when the baby waslast fed and napped was recorded and then the baby was put in theswaddling sack and placed in the device. Data from three accelerometersand a device-mounted camera was recorded to detect the vigor of activityand measure the exact excursions of the baby's head. Each test startedwith the device set at its lowest level for sound and motion, and thedevice responded to the baby's cries. The device was allowed to quicklyadvance through each of its stages as the cries escalated. Once the babywas calmed, the device's motion would slow, in a stepwise fashion, andthe loudness and pitch of the sound would decrease, in a stepwisefashion. This format was repeated 2-4 times during sessions with each ofthe subjects. The first set of studies was done using a prototype with adual motion actuator and the second set of studies was done with aprototype with a single motion actuator.

Results

During twenty-one tests, 19 babies were either significantly calmed orput to sleep by the device (absence of calming was due to hunger). Mostcalming and sleep occurred within 2 minutes of placing the baby in thedevice.

This device is responsive to a baby's needs, such that an infant'supsets are typically soothed by vigorous stimulation to activate thecalming reflex, followed by a diminution of those stimuli to help keepthe calming reflex turned on and sustain the baby in a calm state and/orpromote sleep (i.e. reducing sleep latency and increasing sleepefficiency.

“Sleep latency” may be defined as the length of time between going tobed and falling asleep. “Sleep efficiency” may be defined as the ratioof time spent to the amount of time spent in bed.

It is possible to promote infant calming and sleep through the use ofswaddling plus very specific sound and motion stimuli to activate thecalming reflex.

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

While the disclosure has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present disclosure isnot to be limited by the foregoing examples, but is to be understood inthe broadest sense allowable by law.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the disclosure (especially in the context of thefollowing claims) is to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. Recitation of ranges of valuesherein are merely intended to serve as a shorthand method of referringindividually to each separate value falling within the range, unlessotherwise indicated herein, and each separate value is incorporated intothe specification as if it were individually recited herein. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended merely to better illuminate the disclosureand does not pose a limitation on the scope of the disclosure unlessotherwise claimed. No language in the specification should be construedas indicating any non-claimed element as essential to the practice ofthe disclosure.

While the foregoing written description enables one of ordinary skill tomake and use what is considered presently to be the best mode thereof,those of ordinary skill will understand and appreciate the existence ofvariations, combinations, and equivalents of the specific embodiment,method, and examples herein. The disclosure should therefore not belimited by the above described embodiment, method, and examples, but byall embodiments and methods within the scope and spirit of thedisclosure.

All documents referenced herein are hereby incorporated by reference.

1-10. (canceled)
 11. A device comprising: a movable platform forsupporting an infant; a sensor that generates a signal corresponding toa motor status or a physiologic status of the infant; and a controlsystem that receives and analyzes the generated signal of the motorstatus or the physiologic status of the infant and determines if theinfant is distressed, wherein the control system generates at least onecontrol output that controls a motion of the platform or a sounddirected to the infant if the control system determines that the infantis distressed, and wherein the control system causes a reciprocatingmotion of the platform or a sound to be directed to the infant inresponse to the control output.
 12. The device of claim 11, wherein thecontrol system determines the infant is distressed by determiningwhether a motor or physiologic perturbation greater than an acceptablebaseline has occurred.
 13. The device of claim 11, wherein the controlsystem determines that the infant is a distressed by determining that apause in breathing greater than a predetermined duration has occurred.14. The device of claim 11, wherein the control system determine thatthe infant is distressed by detecting if a heart rate of the infantfalls below a predetermined threshold.
 15. The device of claim 11,wherein the control system generates a control output to control analarm directed to caregivers of the infant if the control systemdetermines that the infant is in distress.
 16. The device of claim 11,wherein an emergency call is initiated in response to the controloutput.
 17. The device of claim 11, wherein the control system causesthe platform to move in a vigorous reciprocating motion and causes and aloud sound to be generated in response to the control output.
 18. Thedevice of claim 17, wherein the motion of the platform has a frequencythat is greater than 0.5 Hz.
 19. The device of claim 17, wherein thesound has an intensity of at least 65 dB.
 20. The device of claim 11,wherein the control system determines that the infant is distressed bydetecting if a oxygen level of the infant falls below a predeterminedthreshold.
 21. A sleep device comprising: a platform for supporting aninfant; a sensor that generates a signal corresponding to a respirationstatus or a cardiovascular status of the infant; and a control systemthat receives signal corresponding to a respiration or a cardiovascularstatus of the infant and utilizes the signal corresponding to arespiration or a cardiovascular status of the infant to determine if theinfant is in distress, wherein the control system generates at least oneoutput that controls a motion of the platform or a sound directed to theinfant if the control system determines that the infant is in distress;and wherein the output causes the platform to move with reciprocatingmotion or a sound to be directed to the infant.
 22. The device of claim21, wherein the control system determines that the infant is in distressby determining that the infant has paused breathing for a predeterminedperiod of time.
 23. The device of claim 21, wherein the cardiovascularstatus is a heart rate of the infant.
 24. The device of claim 21,wherein the cardiovascular status is a heart beat of the infant fallingbelow a predetermined threshold.
 25. The device of claim 21, furthercomprising a sensor that generates a signal indicative of the infant'sbody temperature.